FDA 483 - Fagron Compounding Services - September 21, 2016

This FDA Form 483 documents observations from an inspection concerning the manufacturing and release of drug products, specifically Mitomycin.

**Facility and Operations:** The inspection observed aseptic production of Mitomycin Bladder Irrigation Solution 20mg/40mL in 60 mL Syringes.

**Violations and Observations:** 1. **Inadequate Drug Product Release Testing:** * **Visual Inspection Deficiencies:** Visual inspection of finished drug product lacks adequate training and qualification for inspectors. Training does not include examples of defects, and there is no defect library. Inspectors have not been tested for their ability to locate and categorize defects. * **Non-Compliance with Procedures:** Visual inspection is not performed according to the firm’s written procedure (9.200.FSS), specifically regarding operator actions during inspection. An observed lot (Mitomycin lot 160829@001IF) showed this non-compliance. * **Product Quality Issues:** Retain samples of Mitomycin lot 160328@001F exhibited apparent particulate, clumping, and/or cloudiness in all samples.

2. **Failure to Review Unexplained Discrepancies:** * **Critical Alarm Management:** The firm's (b)(4) system, which (b)(4) such as (b)(4), recorded approximately 766 critical alarms in