FDA 483 - Triangle Compounding Pharmacy Inc - July 13, 2017

The FDA Form 483 details significant deficiencies at a facility producing sterile injectable and ophthalmic drug products.

**Key Violations and Observations:**

* **Inadequate Discrepancy Investigations:** The firm failed to thoroughly investigate unexplained discrepancies, specifically the identification of particulates (lint, particles, fibers) in finished sterile products (e.g., Trimix, Betamethasone, Baclofen injectable batches from Dec 2016 - June 2017). The source of these particulates was not determined. * **Sterility Failure Investigations:** Investigations into six out of seven sterility failures since the previous inspection (April 2015 - Dec 2015, including Ophthalmic Dilating Gel, Avastin, Baclofen PF Injection) did not identify a root cause, and no corrective actions were implemented to prevent reoccurrence. * **Quality Control Unit Deficiencies:** * **Visual Inspection Policy (SOP 2.830):** The firm reprocessed and distributed intrathecal Finished Goods Units (FGUs) despite observing particulates, contrary to their SOP. Visual inspectors were not certified on all container closure systems (1mL, 10mL, 60mL syringes; 5mL clear/amber vials), and unqualified employees performed visual inspections. * **Glassware Washer Operation (SOP 5.985):** Critical endpoints (e.g.,