FDA 483 - Medistat RX, LLC - September 23, 2015

The FDA Form 483 details numerous violations at an unnamed facility producing injectable drug products.

**Key Violations and Observations:**

* **Inadequate Investigation of Discrepancies:** * Environmental monitoring failures (gram-negative bacteria, yeast, mold in ISO 5 hoods) were not adequately investigated. * Multiple drug product lots (Methylprednisolone, Triamcinolone Acetonide, Tri-Mix, HCG, Testosterone Cypionate/Propionate) were released after initial failing sterility results, with investigations concluding "laboratory error" or "analyst error" without sufficient evidence. Products were re-tested by alternative labs and released.

* **Deficient Aseptic Processing Procedures:** * Injectable drug suspensions are sterilized using unvalidated processes and equipment (redacted) in the ISO 8 Prep Room, lacking qualification, cycle validation, and redacted studies. * Operators exhibited poor aseptic technique: handling non-sterile items and resuming compounding without re-sanitizing, pouring non-sterile Benzyl Alcohol into de-pyrogenated containers, and improper hand/finger placement over open vials and during stopper application within ISO 5 hoods. * Smoke studies for clean rooms (including ISO 5 areas) are not performed in static or dynamic conditions. * The redacted used for redacted testing lacks calibration documentation. * No viable air monitoring is conducted within the ISO