Inspections, Compliance, Enforcement, and Criminal Investigations
Gibson Laboratories Inc
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
November 3, 2009
VIA FEDERAL EXPRESS
Chief Executive Officer
Gibson Laboratories, LLC
217 Osseo Avenue North
St. Cloud, MN 56303
Dear Mr. Coborn:
During an inspection of your fum located in Lexington, KY, on August 19 through September 14, 2009, an investigator from the United States Food and Drug Administration ("FDA") determined that your firm is the manufacturer of in vitro diagnostics and agars, such as Modified Thayer agar, Martin agar, Bacti Star Vaginal agar, and Mueller Hinton agar. Under section 201(h) of the Federal Food, Drug and Cosmetic Act (the "Act"), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed that the medical devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to validate a process whose results cannot be fully verified by subsequent inspection and test, and approve the validation according to established procedures, as required by 21 C.F.R. § 820.75(a). Specifically:
(a) The process for sterilizing your medical devices (media) in your autoclaves has not been adequately validated in that: There is no justification that the product loads used during sterilization validation are the hardest to sterilize. There is no justification for using one temperature probe during validation. There is no documented validation for sterilization runs that are less than (b)(4) minutes.
(b) The sterilization process for cleaning the equipment used to fill media has not been properly validated, in that, the validation run was for (b)(4) hours and (b)(4) minutes, but the actual runs reviewed by the FDA investigator had a sterilization time of (b)(4) minutes or less. Additionally, there is no justification that the load of equipment (syringes) used during validation is the hardest to sterilize.
2. Failure to ensure that deterioration or other adverse effects to product do not occur, as required by 21 CFR § 820.140.
Specifically, the labeling for all media states to store the product at 2°C to 8°C. Your firm does not ship the product at 2°C to 8°C as required by the labeling and has no justification documented for shipping the product under non-refrigerated conditions.
3. Failure to adequately investigate the cause of nonconforming product; and failure to identify the actions needed to correct and prevent the recurrence of nonconforming products and other quality problems, as required by 21 CFR§ 820.100(a)(2) and (3). For example:
• Your firm rejected 14 lots of product in 2008 due to contamination and the corrective action was to retrain employees on aseptic technique. This corrective action was not effective. In 2009, your film received 23 complaints on contaminated product and rejected 13 lots of product due to contamination. Additionally, your firm's failure investigations into nonconforming products do not include reviewing the results of environmental testing of the fill room for the days in which contaminated product has been produced. You have failed to conduct a failure investigation that identifies the root cause of contamination; and have not taken a corrective action that reduces the trend of contaminated product.
• The failure investigation, required by your "QC Environmental Testing" procedure, when the colony counts hit the actionable limit for your established "control areas" is not being performed and the corrective action of fogging the room is not being taken.
4. Failure to document the action of retraining employees on aseptic technique to correct and prevent the recurrence of nonconforming product due to contamination, as required by 21 CFR § 820.100(b).
5. Failure to adequately control the environmental conditions, where these environmental conditions could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR § 820.70(c). Specifically,
The process of cleaning the fill room, in which you manufacture media, by fogging the room with a sporicidin has not been validated. The fill room has had 14 days between January 2008-August 2008 and January 2009 and July 2009 where environmental plate counts were at, or above, your film's action limits the day after this room had been fogged.
The inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed to develop written Medical Device Reporting procedures as required by Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR 803.17.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in the initiation of regulatory action without further notice. This may include, but is not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrective actions will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 167, or you may forward a facsimile to her at (513) 679-2773.
Finally, you should know that this letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by the FDA. The specific violations noted in this letter and in the FDA 483s may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt action to correct the violations and to bring your products into compliance.
Teresa C. Thompson
Cc: Naomi Bowling
Gibson Laboratories, LLC
1040 Manchester Street
Lexington, KY 40508