# FDA 483 - AMMAN PHARMACEUTICAL INDUSTRIES - August 15, 2023

Source: https://www.keypedia.com/records/483/amman-pharmaceutical-industries/260101a6-d6a8-497b-bee8-c23aa74a0c94

> FDA 483 for AMMAN PHARMACEUTICAL INDUSTRIES on August 15, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AMMAN PHARMACEUTICAL INDUSTRIES
- Inspection Date: 2023-08-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/amman-pharmaceutical-industries/0c04e991-fda8-450e-bc42-5dabfd034391)
- [WARNING_LETTER - 2023-08-15](https://www.keypedia.com/records/warning_letter/amman-pharmaceutical-industries/0742ffc0-f974-4bfb-a725-339de65fe020)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/amman-pharmaceutical-industries/f61555a9-0ecf-42ee-8239-028212c672d0

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c