November 27, 1990                            DOW CORNING PROPRIETARY

 

To:           Ron Dieck            Dow Corning Wright

                Arnold Lawing       Dow Corning Wright

                Frank Lewis          Dow Corning Wright

 

CC:            George Picha, MD    Applied Medical Technology

 

From:        Les Schnoll            193

 

SUBJECT:    GOOD MANUFACTURING PRACTICES AUDIT AND SANITATION COMPLIANCE AUDIT APPLIED MEDICAL TECHNOLOGY, INC.

 

Attached for your information and review are the copies of the Good Manufacturing Practices Audit and Sanitaiton Compliance Audit where were performed at the Applied Medical Technology, Inc. (AMT) facilities in Independence, Ohio on November 19, 1990.  The audits were designed and conducted to determine the compliance with the Good Manufacturing, Packing, Storage, and Installation of Medical Devices (Title 21 of the Code of Federal Regulations, Part 820).  Moreover, the audit was conducted under the requirements for "critical" devices and components.  According to AMT personnel, the plant has also been audited by the United States Food and Drug Administration in June of 1990.

 

Applied Medical Technology, Inc. is located in several "storefronts" in a retail strip center on Brecksville Road in Independence, Ohio.  AMT currently manufactures and packages a line of microvascular instruments for Dow Corning Wrighte; contract sterilization is performed for AMT by Ethox Corporation (located in Buffalo, New York).  A current contract between AMT and Ethox is in place and appropriate sterilization validation documentation has been prepared by Ethox for those products.  AMT ownership is classified as private (George Picha, M.D.).  Personnel of AMT contacted during the audit included Ms. Pat Gilpin, Mr. Dean Secrest, and Mr. Richard Szczepinski.  All of those individuals report to General Manager (Mr. Gary Pond), who reports to Dr. Picha.  Approximately 50% of the work performed by AMT is classified as commercial; the remaining 50% is classified as proprietary.  Until approximately May of 1990, the company was known as Gastrotech, Inc. The company is currently registered with the United States Food and Drug Administration as Applied Medical Technology, Inc.; the establishement registration number for AMT is 1526012.

 

The facility has not developed any specific "Good Manufacturing Practices Compliance Manual," but "follows" the 4th edition (November 1987) of the Devica Good Manufacturing Practices Manual published by the United States Department of Health and Human Services.  This manual, therefore, becomes their Good Manufacturing Practices Compliance Manual, requiring compliance with all provisions identified therein.

 

Overall the results suggests passable level of compliance with the Good Manufacturing Practices for Medical Devices (indicating the likelihood of a Regulatory Letter being issued by the Agency) and an excellent of compliance with sanitation standards.  Documentation and adherence to procedures, as well as lack of procedures to address complaince with varioius provisions of the regulations, were determined to be the most significant areas of noncompliance.

 

The overall recommendation of this auditor relative to products currently manufactured and packaged for Dow Corning Wright is that conditional approval be granted, pending documented corrective action of all deficiences identified during this audit.  A written response should be submitted to Dow Corning Wright by January 15, 1991; such response should indicate corrective actions and timing.