Augusta Medical Systems, LLC – FDA Warning Letter, Sep 23, 2011

On September 19-23, 2011, an FDA inspection of a firm manufacturing external penile rigidity devices, classified as medical devices under Section 201(h) of the Federal Food, Drug, and Cosmetic Act, revealed significant violations of Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulations (21 CFR Part 820). The devices were deemed adulterated under Section 501(h) of the Act.

Key violations included: 1. **Failure to ensure finished devices meet acceptance criteria (21 CFR Part 820.80(d))**: Device history records for multiple lots of Response II and Touch II devices (e.g., lot # (b)(4)) did not confirm that finished devices met acceptance criteria due to the use of photocopied "Pump Head Final Inspection Sheets." The firm's response was deemed insufficient, requiring further documentation of inspections, identification of ICRs in hazard analysis, and evidence that affected lots met acceptance criteria. 2. **Failure to document personnel training (21 CFR Part 820.25(b))**: No documentation was provided to demonstrate that manufacturing technicians or customer service personnel received training for their assigned duties. The firm's response was found inadequate.

The FDA requires prompt corrective action within fifteen working days, including a plan to prevent recurrence and supporting documentation. Failure to comply may result in regulatory