FDA WARNING_LETTER - Philips Medical Systems (Cleveland) Inc

On June 7, 2011, the FDA issued a Warning Letter to Philips Medical Systems (Cleveland) Inc. following an inspection from August 25 to December 3, 2010. The inspection revealed that the firm's Brilliance, Big Bore, iCT, MX-16 Slice Families of CT products, and Gemini, Gemini LXL/TF, BrightView, JetStream, and Precedence Families of NM products were 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).

Key violations included: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: Issues like incorrect HCOR Scaling for infant scans were not managed through the CAPA system, leading to delayed implementation of fixes. 2. **Failure to implement and record changes for quality problems (21 CFR 820.100(a)(5))**: The firm continued using unbaked anode/cathode power modules despite identified moisture ingress and a supplier's corrective action. 3. **Failure to investigate nonconformities (21 CFR 820.100(a)(2))**: CAPA 10-0