Recordkeeping, Complaint Handling Behind Medgyn’s 12-Count Form 483

Poor recordkeeping appears to be behind the bulk of the 12 observations made in a Form 483 issued to Addison, Ill.-based Medgyn Products.

The Form 483 followed an inspection by the FDA’s Chicago district office that stretched from July 17 to Sept. 6, 2012. Among other deviations, Medgyn did not prove the products were manufactured in keeping with the device master record. For example, a device history record on one curette did not document the packaging, labeling or sterilization process and appeared to have some inconsistent dates. The inspector also noted there was no documentation showing design validation or verification.

The company’s complaint handling also drew concern, as all complaints were attributed to a root cause of “customer order error” or “shipping error.” None was recorded as needing repair, even though other records showed Medgyn had filed MDRs documenting repairs.

Other observations indicate Medgyn did not use appropriate statistical methods to organize service reports and establish causes of product nonconformance. In addition, the Form 483 states the company did not have a management representative in charge of quality systems, employ an expert on importing into the U.S. or perform regular quality audits.

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