# FDA 483 - Alphapharm Pty, Ltd. - June 28, 2024

Source: https://www.globalkeysolutions.net/records/483/alphapharm-pty-ltd/90a03930-eec3-4e21-b283-f49ec697d246

> FDA 483 for Alphapharm Pty, Ltd. on June 28, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Alphapharm Pty, Ltd.
- Inspection Date: 2024-06-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Alphapharm Pty, Ltd. in Carole Park, Australia, a drug manufacturer, revealed significant deficiencies in equipment cleaning and maintenance procedures. Inspectors found that written procedures were inadequate, leading to residue on equipment marked as clean, and that deviations from production controls were not properly justified. These observations indicate a lapse in the firm's adherence to good manufacturing practices.

## Related Officers

- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

Company: https://www.globalkeysolutions.net/companies/alphapharm-pty-ltd/9007b3c5-9b83-4783-b65d-52eb0246708e

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