Recipient: Polymer Technology Systems, Inc.
Product: CardioChek meters
Date: 4/23/2008
The inspection revealed that the devices are adulterated under 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 (CFR), Part 820. These violations include, but are not limited to, the following:
2. Failure to implement procedures to ensure complaints are adequately received, reviewed, and evaluated as required by 21 CFR 820.198(a). For example, your “Customer Call Record and Complaint Handling” procedure, revision 5 dated April 30, 2007 states an inquiry is any request for information regarding a product or technique not related to an alleged deficiency. Five incoming calls were misclassified by your personnel as customer inquiries rather than complaints. The calls consisted of low recovery of patient results, erratic recovery of patient results, and software problems associated with the meters. Therefore, the calls were inadequately reviewed and evaluated per your complaint procedures.
FDA Detroit District Office
