Stokes Healthcare Inc. dba Epicur Pharma – FDA 483, May 23, 2025

**FDA 483 Summary: Stokes Healthcare Inc. (Epicur Pharma)**

**Inspection Dates:** May 13-23, 2025 **Location:** Mount Laurel, NJ **Facility Type:** Producer of Sterile and Non-Sterile Drug Products

**Main Violations/Issues:**

1. **Microbiological Contamination Prevention:** The company has not established or followed procedures to prevent contamination in sterile drug products. Notably, microbial growth was detected during environmental and personnel monitoring in the ISO 5 production area, yet batches of Tacrolimus AQ Ophthalmic Suspension were released without proper labeling for veterinary use. The handling practices of operators posed a contamination risk.

2. **Aseptic Processing Deficiencies:** The firm failed to maintain aseptic conditions due to inadequate cleaning and disinfecting practices. The sporicidal agent did not meet the required contact time, and certain areas within the ISO 5 zone were not thoroughly cleaned. Additionally, the disinfectant efficacy study was insufficient.

3. **Process and Production Control:** There were no adequate written procedures to ensure drug products meet their specified identity, strength, purity, and quality. The process validation for Tacrolimus eye drops lacked established critical control parameters, resulting in multiple out-of-specification batches.

4. **Stability Testing Program:** The firm did not have a written testing program to assess the stability characteristics of drug products, specifically failing to test for impurities in Tacrolimus Ophthalmic Suspension.

**Regulatory Framework:** The observations are based on FDA regulations concerning the production of sterile drug products, focusing on contamination prevention, aseptic processing, and quality assurance.

**Required Actions:** Stokes Healthcare Inc. must address these repeat observations by implementing corrective actions, including establishing validated procedures for contamination prevention, improving aseptic processing protocols, defining critical process parameters, and developing a comprehensive stability testing program. The firm is encouraged to discuss objections or corrective actions with FDA representatives.