FDA WARNING_LETTER - Moor Instruments Ltd - May 06, 2011

On September 6, 2011, the FDA issued a Warning Letter to Moor Instruments Ltd. following an inspection from May 3-6, 2011, at their Devon, UK facility, which manufactures Laser Doppler Blood Flow Products. The inspection found these devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. 352(t)(2) for failing to furnish required information under 21 U.S.C. 360i and 21 CFR Part 803 (Medical Device Reporting).

Key violations include: 1. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to establish adequate CAPA procedures for analyzing quality data sources to identify nonconforming product causes. The firm's response was inadequate, lacking evidence of implemented corrective actions. 2. **Complaint Files (21 CFR 820.198(a)):** Failure to maintain adequate complaint files, with numerous missing fields (e.g., "Action Taken," "Justification for NOT raising Nonconformance," "Date of Resolution"). The firm's response was insufficient, lacking evidence of implemented systemic