Strata Skin Sciences, Inc. – FDA Warning Letter, Aug 22, 2011

The FDA issued a Warning Letter to ProCyte Corporation on January 26, 2012, following an inspection from August 1-22, 2011. The inspection revealed that ProCyte's wound and burn dressings, including GraftCyte Moist Dressing, Complex Cu3 Intensive Hydrating Gel, and Lamin Hydrating Gel, are adulterated and misbranded.

**Quality System Violations (21 CFR Part 820):** 1. **Process Validation (820.75(a)):** Failure to adequately validate packaging and sterilization processes for sterile GraftCyte Moist Dressings. ProCyte confirmed contract manufacturer SOPs but lacked documentation of actual validation studies. ProCyte committed to completing validation protocols and studies by December 23, 2011, and retraining employees by October 14, 2011. 2. **Nonconforming Product Control (820.90(a)):** Failure to adequately control nonconforming products. For example, defects in GraftCyte moist dressings (e.g., tears, incorrect gauze) were identified but not documented on the correct form. ProCyte stated it would document the disposition, review past lots, and revise procedures by October 14, 2011. 3. **Purchasing Controls (820.50):** Failure to ensure purchased products and services