MANI HANOI CO. LTD – FDA Warning Letter, Mar 20, 2014

On June 11, 2014, the FDA issued a Warning Letter to Mani Hanoi Co. LTD following an inspection from March 17-20, 2014, which found their surgical sutures with attached needles to be adulterated. The firm's manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Environmental Control (21 CFR 820.70(c)):** Failure to adequately control environmental conditions. The 2013 particle monitoring report lacked data for (b)(4) particles, despite a work instruction requiring it. The firm's response was inadequate, stating they omitted data due to similar trends and planned to revise procedures, but lacked retrospective review or documentation of the revised instruction. 2. **Process Validation (21 CFR 820.75(c)):** Failure to review and revalidate processes when changes or deviations occur. Documentation for temperature limits in operational qualification for (b)(4) was missing. The firm's response was inadequate, as it lacked evidence of updated procedures, staff training, or review of other process validations. 3. **Corrective and Preventive Action (21 CFR 820.100(a)):** Failure to establish and maintain CAPA procedures. Procedures for analyzing quality data (customer satisfaction,