Inspections, Compliance, Enforcement, and Criminal Investigations
Tri-State Hospital Supply Corporation 03-May-06
Department of Health and Human Services
Public Health Service
Atlanta District Office
May 3, 2006
VIA FEDERAL EXPRESS
Thomas A. Archipley II
Co-Chief Executive Officer
Tri-State Hospital Supply Corporation
301 Catrell Drive
Howell, MI 48843
Dear Mr. Archipley:
During an inspection of your facility located at 3310 S. Main Street, Salisbury, NC, on January 18-26, 2006, our investigator determined that your firm reprocesses various types of surgical stainless steel instruments such as scissors, forceps, hemostats, and needle holders. These are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
This inspection revealed that your 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 their manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System Regulation, as specified in Title 21, Code of Federal Regulations (21 CFR), Part 820. The following significant violation was noted:
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 CFR 820.75(a). Specifically, your firm failed to adequately validate your reprocessing operations. Our investigator noted that on three separate occasions, instruments were reprocessed by subjecting them to an Ethylene Oxide (ETO) cycle of one hour and 20 minutes exposure time. On another three separate occasions, the instruments were subjected to an ETO cycle of 2 hours and 30 minutes. Your initial validation of reprocessed [redacted] Instruments for dated 5/24/96 did not specify a minimum ETO exposure time and/or specific sterilization cycles for reprocessed instruments. Additionally, the validation data from the bioburden profiles and the fractional studies was taken from instruments which had been subjected to an ETO exposure cycle of [redacted] hours. You provided no data during the inspection that would substantiate using an ETO cycle of less than [redacted] hours during the reprocessing operations.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 (copy enclosed) issued to Ms. Stephanie H. Hartley, Quality Manager, at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.
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, no premarket submissions for class III devices to which the Quality System regulation deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunctions, and/or civil money penalties.
We acknowledge receipt of your response letter from Mr. Matt Price, Director of Quality Assurance and Regulatory Affairs dated February 15, 2006. Your response is inadequate because you did not provide specific information about how you were going to validate the process for the [redacted] Instruments. Your response merely indicated that the validation will be revised to include a minimum necessary ETO exposure time. Moreover, your response did not address how you will ensure the adequacy of the validation of the reprocessed instruments that were going to be subjected to the minimum ETO exposure time. As to your response to FDA 483 item #2, your response does not indicate that the packages will be sealed and tested for integrity on the [redacted] sealer, serial # 14182, as specified in the "worst case" contents section of the package validation. You provided no documentation for your response to this item.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. 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 the attention of Serene N. Ackall, Compliance Officer, at the address noted in the letterhead. If you have any questions about this letter, you can contact Ms. Ackall at 404-253-1296.
Atlanta District Office