Taken from the evidentiary CDs from the released Griffin Bell documents.

 

DCCKKA26494

 

November 26, 1990                Dow Corning Proprietary

 

To:    Ron Dieck          DCW

         Arnold Lawing    DCW

         Frank Lewis        DCW

 

From:    Les Schnoll    193

 

Subject:    AUDIT OF APPLIED MEDICAL TECHNOLOGY, INC.

 

Attached please find the detailed report of the audit which I performed at Applied Medical Technology, Inc. (AMT) on Nobemver 19, 1990.  The audit was performed at the request of Frank Lewis.  While a copy of the report will also be sent to George Picha (again at Frank's request), I wanted to make you aware of several items which I did not want to pass along to Dr. Picha (however, you may do so if you wish.

 

Generally speaking, the facility and the personnel employed at AMT give an overall impression of disorganization.  There is a general lackadaisical attitude and the organization is fortunate that they haven't been "caught withtheir pants down".  Their perception is myopic and they do not perceive that their operations are as weak as they really are; one example of this is the manner in which they completed the "Supplier Quality Audit" checklist which I sent to them prior to the audit.  Their responses and the real life situation (as found during the audit) are generally at opposite ends of the spectrum.

 

According to AMT personnel, an audit by an Inspector of the United States Food and Drug Administration was performed in June of 1990; allegedly, the only item identified on a Form 483 which was left with them was the fact that AMT did not have a contract with their contract sterilizer (Ethox Corporation).  This discrepancy has since been corrected.  Again the Inspector allegedly spent two days in the AMT facilities (incredible, considering the dearth of facilities to audit) and found nothing else.  However, in a perod of four hours, I was able to identify problems of such a qualitative and quantitative nature that would warrant a regulatory letter from the District office of the Agency.  I realize that the typical FDA Inspector is not "rocket scientist", but he or she could not possibly be that bad.  I would recommend that we obtain a copy of the Establishment Inspection Report (EIR) filed for the audit through the Freedom of Information Act.  Either Harvy Steinberg or Bailey Lipscomb can do this for you, if you provide the Food and Drug Administration Information officer with the approximate date of the audit, the facility and location, and the establishment registration number (1526012)

 

While we may elect to continue to have AMT manufacture their current product line of microvascular instruments for Dow Corning Wright (and I would strongly recommend that you make that ongoing relationship contingent on documented corrective actions to the deficiencies identified during the audit), there would have to be an incredible leap of faith to consider AMT capable fo manufacturing implant products for sale by Dow Corning Corporation.

 

I trust that this information (and that which follows in the audit report) will provide you with sufficient detail to make a decision concerning an ongoing relationship with Applied Medical Technology, Inc.  Please do not hesitate to contact me if you require any additional assistance.

 

Les