FDA WARNING_LETTER - Contract Medical Manufacturing - September 25, 2008

On November 20, 2008, the FDA issued a Warning Letter to Contract Medical Manufacturing (CMM) following an inspection from September 10-25, 2008. The inspection revealed that CMM's sterile Custom Cranial Implants were adulterated, as manufacturing methods, facilities, or controls did not conform to Quality System (QS) regulations (21 CFR Part 820).

Key violations included: 1. **Lack of Process Validation (21 CFR § 820.75(a)):** No documentation for validation of packaging or ETO sterilization processes. CMM implemented a "stop shipment" and a recall was initiated by their client. 2. **Inadequate Process Monitoring and Control (21 CFR § 820.75(b)):** No procedures for monitoring ETO sterilization and packaging parameters; incorrect recording of relative humidity; failure to maintain/review temperature charts. 3. **Insufficient Quality System Records (21 CFR § 820.186):** No documentation of CMM's review/acceptance of sterilization validation activities performed by a third party, with third-party representatives signing CMM's approval blocks. 4. **Failure of Finished Device Acceptance Procedures (21 CFR § 820.80(d)):** At least seven device history records (DHRs) showed erroneous sterility results