# FDA 483 - AMMAN PHARMACEUTICAL INDUSTRIES - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/amman-pharmaceutical-industries/0c04e991-fda8-450e-bc42-5dabfd034391

> FDA 483 for AMMAN PHARMACEUTICAL INDUSTRIES on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AMMAN PHARMACEUTICAL INDUSTRIES
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Amman Pharmaceutical Industries, a sterile drug manufacturer, revealed severe deficiencies in aseptic processing, environmental monitoring, and laboratory controls. Observations included poor aseptic techniques, inadequate validation of sterile processes, falsified or incomplete laboratory records, and a failure to thoroughly investigate discrepancies. The findings indicate a critical lack of control over sterile drug manufacturing and data integrity.

## Related Documents

- [483 - 2023-08-15](https://www.globalkeysolutions.net/records/483/amman-pharmaceutical-industries/260101a6-d6a8-497b-bee8-c23aa74a0c94)
- [WARNING_LETTER - 2023-08-15](https://www.globalkeysolutions.net/records/warning_letter/amman-pharmaceutical-industries/0742ffc0-f974-4bfb-a725-339de65fe020)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1