FDA 483 - RXQ Compounding LLC - June 06, 2019

The FDA Form 483 details numerous deficiencies at the facility, primarily concerning quality control, sterile manufacturing, and personnel training.

**Key Violations and Observations:**

* **Inadequate Investigations (Observation 1):** The firm failed to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. This includes approximately eight sterility failure investigations since August 2017 (e.g., Ascorbic Acid, Sodium Bicarbonate, Procaine HCl, Lidocaine HCl), which were incomplete, lacked environmental monitoring, were untimely, and had inadequate root cause assessments or CAPAs. A complaint investigation for Ascorbic Acid crystallization (RCA-2019-013) identified 18 affected lots but failed to determine a root cause or take further action. Approximately 107 OOS potency investigations since August 2017 were also deficient, with products released without identified root causes (e.g., Ascorbic Acid, Trypan Blue). Endotoxin failure investigations for methylcobalamin also cited the active pharmaceutical ingredient as the root cause without further detail. * **Microbiological Contamination Prevention (Observation 2 - Repeat Observation):** Procedures to prevent microbiological contamination of sterile drug products were not established or followed. This included improper aseptic technique by operators (e.g., blocking first pass air, not changing gloves after touching non-sterile items, using wipes exposed to lower-grade air in ISO