Central Surgical Co. Ltd. – FDA Warning Letter, Aug 14, 2012

On December 27, 2012, the FDA issued a Warning Letter to Central Surgical Co. Ltd. in London, United Kingdom, following an inspection on August 13-14, 2012. The inspection revealed that the firm's oocyte aspiration needles are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

The FDA identified four key violations: 1. **Failure to validate processes (21 CFR 820.75(a)):** The firm's (b)(4) sterilization process was not validated, and documentation for initial validation was missing. The firm's response regarding re-validation was inadequate, lacking technical information. 2. **Failure to establish corrective and preventive action procedures (21 CFR 820.100(a)(3)):** The firm failed to identify actions to correct and prevent recurrence when (b)(4) bio-burden limits were exceeded. The response was inadequate, lacking documentation of retraining and retrospective review of bio-burden results. 3. **Failure to control production processes (21 CFR 820.70(a)):** (b)(4) sterilization batches in 2012 exceeded the specified load capacity of (