FDA WARNING_LETTER - SYNECCO LTD. - July 10, 2013

On November 18, 2013, the FDA issued a Warning Letter to Synecco Ltd. following an inspection from July 8-10, 2013, in Ningbo, China. The firm, a contract manufacturer and sterilizer of medical devices like feeding tubes and liquid medication dispensers for U.S. distribution, was found to have adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)(3)):** A corrective action for a syringe defect lacked identified actions to prevent recurrence and an appropriate sampling plan for final inspection. The firm's response was inadequate as the sampling plan was not addressed, and corrective actions were incomplete. 2. **Failure to maintain complaint investigation records (21 CFR 820.198(e)):** Complaints from May 2012 to June 2013 lacked crucial information such as receipt date, source, complainant feedback, root cause, and disposition date. The adequacy of the firm's response could not be determined as corrective actions were incomplete. 3. **Failure to validate processes (21 CFR 820.75(a)):