Anchor Products Company, Inc – FDA Warning Letter, Jun 4, 2010

The FDA issued a Warning Letter to Anchor Products Company, Inc. following an inspection from May 26 to June 4, 2010, at their Addison, Illinois facility, which manufactures medical devices like the Anchor Tissue Retrieval System. The inspection revealed that the devices are adulterated under section 501(h) of the Act due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820), and misbranded under section 502(t)(2) for failing to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803). Key QS violations included inadequate procedures for complaint handling (receiving, reviewing, evaluating, investigating, and record-keeping), insufficient corrective and preventive action (CAPA) procedures, failure to control design changes, inadequate document control, and an insufficient organizational structure. MDR violations involved the failure to submit timely reports for serious injuries and device malfunctions likely to cause serious injury if recurrent, along with a lack of internal systems for identifying and evaluating MDR-reportable events. The firm's July 22, 2010, response to the Form FDA 483 was not addressed due to late submission. Anchor Products Company must promptly correct these violations and provide a written response within fifteen working days, detailing corrective actions, prevention plans, and a timetable. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.