| Public Health Service Food and Drug Administration |
New Orleans District 404 BNA Drive Building 200 – Suite 500 Nashville, TN 37217 Telephone: (615) 366-7801 FAX: (615) 366-7802 |
Department of Health and Human Services
October 1, 2010
WARNING LETTER NO. 2011-NOL-01
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Samuel J. Babb, President
368 East Tennessee Avenue
Oak Ridge, Tennessee 37830
Dear Mr. Babb:
During an inspection of your facility, located at 368 East Tennessee Avenue, Oak Ridge, Tennessee, on August 9, 10, and 11, 2010, an investigator from the United States Food and Drug Administration (FDA) determined your firm manufactures sterile Trans-Urethral-Resection (TUR) aprons. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 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 these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice requirements of the Quality System regulation, Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). We received your response, dated August 21, 2010, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, issued to you on August 11, 2010. We are aware you provided the investigator with proposed written standard operating procedures (SOP) which were not signed as approved. We address this response below in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to implement corrective and preventive action (CAPA) when the dose audit of TUR apron, [(b)(4)] did not meet sterility specifications during a dose audit study conducted during March through April, 2010, as required by 21 CFR 820.100(b). You received a report from your contract sterilizer, [(b)(4)], on or about April 26, 2010, explaining the sterility failure; however, you distributed aprons from this lot without investigating the cause of the failure or taking corrective action to keep these products from distribution channels. For example, you distributed [(b)(4)] from that lot on April 26, 2010, without taking a corrective action. The FDA has evaluated the possible risk to patients from the use of or exposure to the affected aprons. The FDA has determined the use of the affected aprons may cause an infection of the surgical site, which may result in sepsis, delayed or poor wound healing, and prolonged hospital stays.
We[p1] reviewed your proposed CAPA SOP and conclude it is inadequate because it does not address who is responsible for reviewing and approving the proposed corrective/preventive action. In addition, this procedure fails to address nonconforming products in distribution channels and the steps for verifying or validating the corrective action to ensure such action is effective and does not adversely affect the finished device.
2. Failure to establish and maintain procedures for monitoring and controlling validated processes, as required by 21 CFR 820.75(b). Specifically, your firm does not have data to support the five year expiration date printed on the label of your TUR Apron.
You explain in your response you will begin stability studies on your product. You have not addressed how this will affect the products currently in distribution for which you have no data to support the sterility or functionality specifications throughout the expiration period.
3. Failure to include the primary identification label and labeling used for each production unit in the device history records (DHR), as required by 21 CFR 820.184(e). Specifically, all DHRs reviewed during the inspection did not contain a copy of the labeling used for the production lot. Further, after the inspection we reviewed the [(b)(4)] and note it fails to require a copy of the printed label in the DHR.
You explain in your response you will make a copy of the labeling used on the device and shipping box and file the copy in the DHR.
4. Failure to evaluate nonconforming product to include a determination of the need for an investigation and notification of the persons or organization responsible for the nonconformance, as required by 21 CFR 820.90(a). For example: [(b)(4)] were rejected during the manufacturing of TUR Apron, [(b)(4)] were rejected during the manufacture of TUR Apron, [(b)(4)] were rejected during the manufacture of TUR Apron, [(b)(4)]. You did not determine if there was a need to investigate the cause of these nonconforming aprons.
We reviewed your procedure. Although this procedure contains references to the possibility of generating a CAPA, it does not define the threshold of nonconforming units which will cause your firm to generate a CAPA.
5. Failure to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants based on evaluation results, as required by 21 CFR 820.50(a)(2). Specifically, your firm failed to define and implement adequate quality controls which must be met by suppliers and contractors.
You explain in your response you will follow up on the supplier evaluation questionnaires mailed to your suppliers in January 2010; however, you have not established specific requirements to which all purchases or services must conform.
6. Failure to establish and maintain procedures for acceptance activities of incoming product, including inspections, tests, or other verification activities, as required by 21 CFR 820.80. Specifically, you do not conduct any quantitative testing of incoming components or perform quantitative testing of package and seal integrity during packaging operations. Furthermore, you failed to document acceptance activities, as required by 21 CFR 820.80(e). For example, your firm failed to document inspections, tests, and other verification activities conducted on TUR Apron, [(b)(4)], when it was returned from the sterilizer.
7. Failure of management with executive responsibility to review the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of this part, as required by 21 CFR 820.20(c). For example, your firm failed to establish and implement written management review procedures.
We have reviewed the [(b)(4)] in your response and have concluded it is inadequate because lacks a review and approval signature.
Though not discussed during the inspection, a review of the inspectional findings after the inspection revealed additional deviations:
- Failure to establish and maintain procedures adequate to control environmental conditions which could adversely effect product quality, as required by 21 CFR 820.70(c). Specifically, you fail to monitor or control environmental conditions which affect the bioburden on the TUR Aprons. During March 2010, TUR Apron [(b)(4)] was determined to contain bioburden average [(b)(4)] CFU’s, which is greater than [(b)(4)] the bioburden contained on the TUR Aprons originally used to validate the sterilization process during October 2009.
- Failure to examine the labeling for accuracy, including the correct expiration date and lot number, as required by 21 CFR 820.120(b). For example, you print finished product labels; however, you do not document this operation nor do you verify the printed lot number and expiration date.
- Failure to monitor and control process parameters and component and device characteristics during production, as required by 21 CFR 820.70(a)(2). You do not document the steps during set up of the heat sealer and your [(b)(4)] does not include instructions to document those steps.
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations which exist in connection with your product. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure your firm complies with all requirements of Federal law and FDA regulations. Recurrence of the aforementioned deviations may result in legal action without further notice, including, without limitation, seizure and injunction.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, premarket approval 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 in writing 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 recurring. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions 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 Mark W. Rivero, Compliance Officer, at the above address. If you have any questions about the content of this letter please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/S/
H. Tyler Thornburg
District Director
New Orleans District
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