FDA - Inspection Citations
 Share
The version of the browser you are using is no longer supported. Please upgrade to a supported browser.Dismiss

View only
 
 
ABCDEFGHI
1
FirmCityStateCountry
Inspection End Date
CenterCFRDescriptiondatayear
2
Central Admixture Pharmacy Services IncLanhamMDUS10/12/2005Drugs21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations.
2006
3
Central Admixture Pharmacy Services IncLanhamMDUS10/12/2005Drugs21 CFR 211.125(f)
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed.
2006
4
Central Admixture Pharmacy Services IncLanhamMDUS10/12/2005Drugs21 CFR 211.130
Procedures designed to assure that correct labels and labeling are used for drug products are not followed.
2006
5
Central Admixture Pharmacy Services IncLanhamMDUS10/12/2005Drugs
21 CFR 211.188(b)(13)
Batch production and control records do not include results of examinations made of packaged and labeled products for correct labeling.
2006
6
Central Admixture Pharmacy Services IncLanhamMDUS10/12/2005Drugs21 CFR 211.188(b(3)
Batch production and control records do not include the specific identification of each batch of component and in-process material used for each batch of drug product produced.
2006
7
Central Admixture Pharmacy Services IncLanhamMDUS10/12/2005Drugs
21 CFR 211.188(b)(8)
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
2006
8
Central Admixture Pharmacy Services IncLanhamMDUS10/12/2005Drugs21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
2006
9
Central Admixture Pharmacy Services IncLanhamMDUS10/12/2005Drugs
21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
2006
10
Respa Pharmaceuticals Inc.AddisonILUS9/29/2006Drugs21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
2006
11
Haifa Smoked Fish, Inc.JamaicaNYUS10/17/2005Foods21 CFR 123.11(b)
You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, and protection of food, food packaging material, and food contact surfaces from adulteration.
2006
12
Haifa Smoked Fish, Inc.JamaicaNYUS10/17/2005Foods21 CFR 123.6(b)
You did not implement the monitoring, recordkeeping, and verification procedures listed in your HACCP plan.
2006
13
Haifa Smoked Fish, Inc.JamaicaNYUS10/17/2005Foods21 CFR 123.6(c)(1)
Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.
2006
14
Haifa Smoked Fish, Inc.JamaicaNYUS10/17/2005Foods21 CFR 123.6(c)(6)
Your HACCP plan does not list verification procedures and frequencies that have been developed to ensure that the HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
2006
15
Haifa Smoked Fish, Inc.JamaicaNYUS10/17/2005Foods21 CFR 123.7(a)
You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected.
2006
16
Haifa Smoked Fish, Inc.JamaicaNYUS10/17/2005Foods
21 CFR 123.8(a)(3)(i)
Your review of critical control point monitoring records does not ensure that the records are complete and verify that they document values that are within critical limits.
2006
17
Haifa Smoked Fish, Inc.JamaicaNYUS10/17/2005Foods
21 CFR 123.8(a)(3)(iii)
You did not review some of your calibration records within a reasonable time after the records were made.
2006
18
Intra-Lock InternationalBoca RatonFLUS10/4/2005Devices21 CFR 820.22
Procedures for conducting quality audits were not complete.
2006
19
Intra-Lock InternationalBoca RatonFLUS10/4/2005Devices21 CFR 820.75(a)
Process validation activities and results have not been fully documented.
2006
20
Medtronic MiniMedNorthridgeCAUS10/3/2005Devices21 CFR 820.198(a)Complete complaint files are not maintained.2006
21
Medtronic MiniMedNorthridgeCAUS10/3/2005Devices21 CFR 820.75(a)
A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated and approved according to established procedures.
2006
22
Robert M. Peroutka, MDLuthervilleMDUS10/13/2005
Bioresearch monitoring
21 CFR 50.20
Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception.
2006
23
Robert M. Peroutka, MDLuthervilleMDUS10/13/2005Devices21 CFR 812.100
An investigation was not conducted according to the investigational plan.
2006
24
Gage Food Products, LLCBensenvilleILUS10/3/2005Foods21 CFR 110.40(a)
The materials of equipment does not allow proper cleaning.
2006
25
Gage Food Products, LLCBensenvilleILUS10/3/2005Foods21 CFR 110.40(b)
Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles and the opportunity for growth of microorganisms.
2006
26
Gage Food Products, LLCBensenvilleILUS10/3/2005Foods21 CFR 110.40(f)
An inadequate number of instruments used for measuring, regulating, and recording conditions that control or prevent the growth of undesirable microorganisms.
2006
27
Gage Food Products, LLCBensenvilleILUS10/3/2005Foods21 CFR 110.80
All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.
2006
28
Gage Food Products, LLCBensenvilleILUS10/3/2005Foods21 CFR 110.80(a)(1)
Failure to store raw materials in a manner that protects against contamination.
2006
29
Gage Food Products, LLCBensenvilleILUS10/3/2005Foods
21 CFR 110.80(b)(14)
Failure to adequately maintain at a safe moisture level foods that rely on the control of water activity to prevent the growth of undesirable microorganisms.
2006
30
Greenhalgh M.D., David G.SacramentoCAUS10/27/2005
Bioresearch monitoring
21 CFR 50.27(a)
Informed consent was not properly documented in that the written informed consent used in the study was not dated by the subject or the subject's legally authorized representative at the time of consent.
2006
31
Greenhalgh M.D., David G.SacramentoCAUS10/27/2005Devices21 CFR 812.100
An investigation was not conducted according to the signed agreement and investigational plan.
2006
32
Greenhalgh M.D., David G.SacramentoCAUS10/27/2005Devices
21 CFR 812.140(a)(2)(i)
Records of receipt and disposal of a device that relate to the dates of receipt of the device are not all complete.
2006
33
Greenhalgh M.D., David G.SacramentoCAUS10/27/2005Devices
21 CFR 812.140(a)(3)
Records of each subject's case history are not all accurate and complete.
2006
34
Greenhalgh M.D., David G.SacramentoCAUS10/27/2005Devices
21 CFR 812.140(a)(4)
Records showing dates and reasons for each deviation from the protocol are not all complete.
2006
35
Greenhalgh M.D., David G.SacramentoCAUS10/27/2005Devices
21 CFR 812.150(a)(1)
A complete and accurate report of an unanticipated adverse device effect was not prepared and submitted to the sponsor.
2006
36
Greenhalgh M.D., David G.SacramentoCAUS10/27/2005Devices
21 CFR 812.150(a)(3)
Progress reports on the investigation were not submitted at least yearly to the sponsor.
2006
37
Greenhalgh M.D., David G.SacramentoCAUS10/27/2005Devices
21 CFR 812.150(a)(4)
Prior approval was not obtained from the sponsor for changes in and deviations from an investigational plan in a non-emergency situation.
2006
38
Hannaford Brothers Company
Schodack Landing
NYUS10/6/2005Foods21 CFR 123.8(a)(3)
You did not review some of your critical control point monitoring records within one week of the day that the records are made.
2006
39
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
2006
40
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.110(a)
Written procedures are not established that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch.
2006
41
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.110(c)
In-process materials are not tested for identity, strength, quality, and purity and approved or rejected by the quality control unit during the production process and after storage for long periods.
2006
42
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.110(d)
Rejected in-process materials are not identified and controlled under a quarantine system to prevent their use in manufacturing or processing operations for which they are unsuitable.
2006
43
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.122(a)
There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, examination, and testing of labeling and packaging materials.
2006
44
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.137(a)
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
2006
45
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality and purity.
2006
46
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
2006
47
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products.
2006
48
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.167(c)
Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient.
2006
49
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.170(a)
A sample which is representative of each lot in each shipment of each active ingredient is not retained.
2006
50
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not described in a written procedure.
2006
51
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
2006
52
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.22(a)There is no quality control unit.2006
53
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.42(a)
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
2006
54
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.42(c)(1)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
2006
55
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.46(c)
The production area air supply lacks an appropriate air filtration system.
2006
56
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.56(b)
There is a lack of written procedures assigning responsibility, providing cleaning schedules, and describing in sufficient detail the methods, equipment and materials to be used for sanitation.
2006
57
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
2006
58
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
2006
59
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.80(b)
There was a failure to handle and store components, drug product containers, and closures at all times in a manner to prevent contamination.
2006
60
Cascadia Manufacturing, Inc. d.b.a. Oramelts Corporation
BellevueWAUS10/18/2005Drugs21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
2006
61
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.10(b)(1)
Suitable outer garments are not worn that protect against contamination of food, food contact surfaces, and food packaging materials.
2006
62
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.10(b)(2)
Employees in contact with food, food-contact surfaces, and food-packaging materials were not maintaining adequate personal cleanliness.
2006
63
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.10(b)(3)
Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.
2006
64
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.10(b)(9)
Failure to take necessary precautions to protect against contamination of food and food contact surfaces with microorganisms and foreign substances.
2006
65
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.35(a)
Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, and food-packaging materials.
2006
66
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.40(a)
The design and materials of equipment does not allow proper cleaning and maintenance.
2006
67
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.40(c)
Non food-contact equipment in manufacturing areas is not constructed so that it can be kept in a clean condition.
2006
68
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.80
Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.
2006
69
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.80
Food which has become contaminated to the extent of being adulterated within the meaning of the Act is not rejected or if permissible, treated or processed to eliminate the contamination..
2006
70
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.80(b)(5)
Failure to handle work-in-progress in a manner that protects against contamination.
2006
71
Sween, E.A., Co. dba Deli ExpressEden PrairieMN10/6/2005Foods21 CFR 110.80(b)(8)
Failure to take effective measures to protect against the inclusion of metal and extraneous material in food.
2006
72
Providence Milwaukie HospitalMilwaukieORUS10/4/2005Biologics
21 CFR 606.160(a)(1)
Records fail to be as detailed as necessary so as to provide a complete history of the work performed.
2006
73
Bread & Chocolate, Inc.AlexandriaVAUS10/1/2005Foods21 CFR 110.10(b)(4)
Employees failed to remove unsecured jewelry or other objects which might fall into food.
2006
74
Bread & Chocolate, Inc.AlexandriaVAUS10/1/2005Foods21 CFR 110.10(b)(5)
Gloves used in food handling are not maintained in an intact, clean, and sanitary condition.
2006
75
Bread & Chocolate, Inc.AlexandriaVAUS10/1/2005Foods21 CFR 110.10(b)(9)
Failure to take necessary precautions to protect against contamination of food with microorganisms and foreign substances.
2006
76
Bread & Chocolate, Inc.AlexandriaVAUS10/1/2005Foods21 CFR 110.35(c)
Effective measures are not being taken to exclude pests from the processing areas.
2006
77
Bread & Chocolate, Inc.AlexandriaVAUS10/1/2005Foods21 CFR 110.35(d)
Failure to clean food-contact surfaces as frequently as necessary to protect against contamination of food.
2006
78
Bread & Chocolate, Inc.AlexandriaVAUS10/1/2005Foods21 CFR 110.80(b)(7)
Failure to maintain equipment, containers and utensils used to convey food in a manner that protects against contamination.
2006
79
Restaurant Depot EnterprisesColumbusOHUS10/7/2005Foods21 CFR 123.6(b)
Your HACCP plan is not specific to the location where the fish are processed.
2006
80
Restaurant Depot EnterprisesColumbusOHUS10/7/2005Foods21 CFR 123.6(c)(2)
Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.
2006
81
Restaurant Depot EnterprisesColumbusOHUS10/7/2005Foods21 CFR 123.6(d)
Your HACCP plan was not signed and dated upon initial acceptance, upon modification, and at least annually.
2006
82
Restaurant Depot EnterprisesColumbusOHUS10/7/2005Foods
21 CFR 123.8(a)(3)(iii)
You did not review your calibration records within a reasonable time after the records were made.
2006
83
Restaurant Depot EnterprisesColumbusOHUS10/7/2005Foods21 CFR 123.9(a)
Your records do not include the date and time of the activity the record reflects and signature and initials of the person performing the operation.
2006
84
Endoplus, Inc.Buffalo GroveILUS10/6/2005Devices21 CFR 820.120Labeling procedures were not documented.2006
85
Endoplus, Inc.Buffalo GroveILUS10/6/2005Devices21 CFR 820.184(d)
The device history record does not include complete acceptance records that demonstrate the device is manufactured in accordance with the device master record.
2006
86
Endoplus, Inc.Buffalo GroveILUS10/6/2005Devices21 CFR 820.22
Procedures for conducting quality audits were not complete.
2006
87
Endoplus, Inc.Buffalo GroveILUS10/6/2005Devices21 CFR 820.30(a)
Procedures to control the design process of the device were not complete.
2006
88
Endoplus, Inc.Buffalo GroveILUS10/6/2005Devices21 CFR 820.30(i)
Procedures were not completed and followed for the documentation and validation or verification of design changes before their implementation.
2006
89
Endoplus, Inc.Buffalo GroveILUS10/6/2005Devices21 CFR 820.40Document control procedures were not complete.2006
90
Endoplus, Inc.Buffalo GroveILUS10/6/2005Devices21 CFR 820.80(c)
Acceptance procedures to ensure that specified requirements for in-process product are met were not implemented.
2006
91
Endoplus, Inc.Buffalo GroveILUS10/6/2005Devices21 CFR 820.90(a)
Procedures for addressing the documentation, evaluation, and investigation of nonconforming product were not complete.
2006
92
Endoplus, Inc.Buffalo GroveILUS10/6/2005Devices21 CFR 820.90(b)(2)
Rework and reevaluation activities have not been fully documented in the device history record.
2006
93
Franklin Foods, a Division of Franklin Farms Inc.
North FranklinCTUS10/6/2005Foods21 CFR 110.35(a)
Failure to maintain buildings and fixtures in repair sufficient to prevent food from becoming adulterated.
2006
94
Franklin Foods, a Division of Franklin Farms Inc.
North FranklinCTUS10/6/2005Foods21 CFR 110.40(c)
Non food-contact equipment in manufacturing areas is not constructed so that it can be kept in a clean condition.
2006
95
Franklin Foods, a Division of Franklin Farms Inc.
North FranklinCTUS10/6/2005Foods21 CFR 110.80(b)(1)
Failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing.
2006
96
Franklin Foods, a Division of Franklin Farms Inc.
North FranklinCTUS10/6/2005Foods21 CFR 110.80(b)(2)
Failure to manufacture foods under conditions and controls necessary to minimize contamination.
2006
97
Padilla Americo, MDMiamiFLUS10/5/2005
Bioresearch monitoring
21 CFR 312.60
An investigation was not conducted in accordance with the investigational plan.
2006
98
Padilla Americo, MDMiamiFLUS10/5/2005
Bioresearch monitoring
21 CFR 312.62(b)
Failure to prepare or maintain accurate case histories with respect to observations and data pertinent to the investigation.
2006
99
Hicks OrchardGranvilleNYUS10/7/2005Foods21 CFR 110.10(b)(4)
Employees failed to remove unsecured jewelry or other objects which might fall into food and equipment.
2006
100
Hicks OrchardGranvilleNYUS10/7/2005Foods21 CFR 120.6(c)
You do not maintain sanitation standard operating procedure records that document the monitoring of conditions and practices during processing.
2006
Loading...