FDA WARNING_LETTER - Stingray Surgical Products, LLC - December 05, 2011

On May 3, 2012, the FDA issued a Warning Letter to Stingray Surgical Products, LLC, following an inspection from November 30 to December 5, 2011. The inspection revealed that the firm's Electrosurgical Forceps are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate processes (21 CFR 820.75(a)):** Inadequate validation of coating, welding, cap application, and Ethylene Oxide (EO) and steam sterilization processes. The firm's response was deemed inadequate, lacking evidence of systemic corrective actions or employee training on revised procedures. 2. **Inadequate change control procedures (21 CFR 820.70(b)):** Failure to adequately verify/validate changes, such as extending the shelf life of expired Corvel Black coating without proper documentation or scientific justification. 3. **Inadequate process control procedures (21 CFR 820.70(a)):** Failure to document the use of a specific tool and parameters in manufacturing procedures. 4. **Inadequate incoming product acceptance procedures (21 CFR 820.80(b)):** Failure to complete receiving inspection activities for