Rocket Medical Plc – FDA Warning Letter, Jul 14, 2011

On October 13, 2011, the FDA issued a Warning Letter to Rocket Medical Plc following a July 11-14, 2011 inspection of their Washington, UK facility, which manufactures IVF devices. The inspection found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) Current Good Manufacturing Practice (CGMP) requirements.

The FDA cited five violations: 1. **Failure to control device design (21 CFR 820.30(a)):** Design procedure SOP 2200 lacked requirements for design planning, inputs, outputs, verification, validation, transfer, and risk assessment. This was a repeat observation from a 2006 inspection. 2. **Inadequate corrective and preventive actions (CAPA) procedures (21 CFR 820.100(a)):** SOP 3104 did not include requirements for analyzing potential causes, investigating nonconformities, verifying/validating CAPAs, or disseminating quality problem information. Specific CAPAs (e.g., for IVF product testing failures and a catheter complaint) lacked documented investigations, implementation, or verification. 3. **Failure to control environmental conditions (21 CFR 820.70(c)):** SOP