FDA 483 - Customcoatial Compounding, LLC - March 08, 2019

This FDA Form 483 details multiple deficiencies in aseptic processing and quality control for sterile drug products, specifically intrathecal finished product lots.

**Key Violations and Observations:**

* **Inadequate Microbiological Contamination Prevention:** * Operator (b)(6) failed to sanitize individual packages inside a plastic bin immediately prior to introduction into the ISO 5 LAFW on 02/27/19 and 02/28/19, impacting multiple intrathecal lots. * Both primary aseptic production operators (staff pharmacists (b)(6) and (b)(6)) failed their 01/24/19 media fills due to exceeding gloved fingertip CFU limits (4 CFU for (b)(6) and 8/6 CFU for (b)(6)). Despite failing, their records were marked "pass," and no deviations were opened. Both operators produced sterile products from 01/25/19 through 03/04/19 and 03/06/19, respectively. Operator (b)(6) also lacked routine personnel monitoring. * Airflow visualization study for the LAFW (05/25/17) showed insufficient smoke, stagnation, and turbulence, and dynamic conditions were not representative of production.

* **Deficient Environmental Monitoring and Action:** * Operator (b)(6)'