FDA 483 - Wells Pharma of Houston LLC - March 28, 2025

An FDA inspection of Wells Pharma of Houston LLC, an outsourcing facility located at 9265 Kirby Dr, Houston, TX, was conducted from March 17-28, 2025. The inspection, led by Investigator Jazmine N Brown, identified nine observations regarding the firm's sterile drug product manufacturing and quality systems.

**Key Violations and Observations:**

1. **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products were not established, written, or followed. * Aseptic pharmacy technicians were observed blocking first-pass air in ISO 5 Laminar Air Flow Hoods (LAFHs) during drug product preparation (Fentanyl, Midazolam, Ketamine). * Operator media fills were deficient, not fully qualifying sterile operators for all container closure units, fill volumes, or batch sizes. * Media fill programs did not include all equipment used in sterile drug preparation (e.g., Ropivacaine pumps, Cefazolin preparation unit). * Aseptic process validation media fills failed to represent worst-case scenarios (batch size, volume, time, interventions) and did not simulate actual single-operator production. * Smoke studies were deficient in visualizing unidirectional airflow during dynamic movements in LAFHs. * Operators used sterile goggles with holes, allowing potential particulate egress, and were observed leaning into ISO 5 LA