FDA WARNING_LETTER - Philips Medical Systems - August 09, 2010

This FDA Warning Letter, dated March 28, 2011, is an amendment to a previous letter from March 22, 2011, correcting typographical errors and extending the response deadline. It addresses violations observed during an inspection from April 5, 2010, to August 9, 2010, at a Seattle, Washington firm manufacturing HeartStart, FRx, FR2+, and HS1 lines of Automated External Defibrillators (AEDs).

The inspection revealed that the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's responses from August 30, 2010, and October 21, 2010, were deemed inadequate for most violations.

Key violations include: 1. **Failure to adequately verify or validate CAPA effectiveness (21 CFR 820.100(a)(4))**: Evidenced by 87 complaints, including one death, related to detached/missing magnets on HS1 AED Pads Cartridges, despite multiple CAPAs and design changes lacking effectiveness validation. 2. **Failure to adequately implement CAPA changes (21 CFR 820.1