FDA 483 - AMMAN PHARMACEUTICAL INDUSTRIES - August 15, 2023

This FDA Form 483 document details significant deficiencies observed during an inspection of a facility manufacturing sterile drug products for the US market, specifically on aseptic fill lines including (b)(4).

**Key Violations and Observations:**

* **Microbiological Contamination Prevention (Observation #1):** Procedures to prevent microbiological contamination are not established or followed. Numerous instances of poor aseptic behavior were observed, including operators not wearing goggles, exposing skin in Grade A areas, leaning over open sterile components, touching faces before interventions without hand disinfection, handling sterile components directly without forceps, re-placing potentially contaminated bottles, improper handling of sterilized tubing, touching exposed product, leaving open bottles/dropper stations unnecessarily, touching Grade A surfaces after kneeling, bringing unsanitized component bags into Grade A, crawling/kneeling/sitting without gown changes, handling rejected/disinfectant bottles without glove changes, and bringing a cell phone into the aseptic room. Specific examples from August 7-9, 2023, highlight repeated manual interventions without proper disinfection or use of forceps, and re-use of contaminated components.

* **Aseptic Process Validation (Observation #2):** Aseptic process validation is inadequate. Smoke studies are not dynamic, do not cover the entire line, or evaluate set-up/operation/interventions, and static studies show air turbulence. Media fills are not representative, lack established intervention numbers, and routine/media fill batch records do not document