FDA WARNING_LETTER - Albert Browne Ltd. - March 01, 2012

On May 29, 2012, the FDA issued a Warning Letter to Albert Browne Ltd. following an inspection from February 27 to March 1, 2012, at their Leicester, UK facility. The inspection found that the firm's chemical indicators for sterilization processes, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Design Validation (21 CFR 820.30(g)):** Failure to establish and maintain adequate procedures for design validation, with acceptance criteria not established prior to testing and approval forms completed before testing initiation. 2. **Rework Procedures (21 CFR 820.90(b)(2)):** Absence of procedures for rework of nonconforming products, as observed in specific works orders. 3. **Acceptance Procedures (21 CFR 820.80(c)):** Inadequate acceptance procedures for in-process products, including undocumented Pass/Fail testing and unlogged Out-of-Specification (OOS) results. 4. **Equipment Maintenance (21 CFR 820.70(g)(1)):** Failure to maintain adequate schedules and documentation for equipment adjustment, cleaning, and