Jieying Laboratory Inc – FDA Warning Letter, Oct 30, 2014

On March 9, 2015, the FDA issued a Warning Letter to Jieying Laboratory, Inc. following an inspection from October 27-30, 2014, in Longueuil, Quebec, Canada. The inspection revealed that the firm's Class II assisted reproduction tools are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

The letter details numerous violations, including: 1. **Failure to establish and maintain design control procedures** (21 CFR 820.30(a)), lacking requirements for design planning, input, output, review, verification, validation, transfer, changes, and design history files. 2. **Failure to validate processes** where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), specifically for sterile micro-tool manufacturing and sterilization processes (e.g., lack of yearly bioburden/sterility recovery testing, revalidation for material changes). 3. **Failure to establish procedures for nonconforming product review and disposition** (21 CFR 820.90(b)(1)). 4. **Failure to develop, conduct, control, and monitor production processes** to ensure device conformity (2