# FDA 483 - Almac Sciences Limited - March 10, 2023

Source: https://www.globalkeysolutions.net/records/483/almac-sciences-limited/b304206f-3d48-43c8-a556-78fad99c5f30

> FDA 483 for Almac Sciences Limited on March 10, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Almac Sciences Limited
- Inspection Date: 2023-03-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Almac Sciences Limited, a drug substance manufacturer in Craigavon, United Kingdom, was cited for two significant observations during an FDA inspection. The firm failed to adequately investigate unknown impurities in drug substance batches manufactured on-site, allowing undetected peaks to go uninvestigated. Additionally, the company lacked robust controls for its water system, resulting in persistent microbiological contamination with objectionable organisms.

## Related Officers

- [Libia Lugo](https://www.globalkeysolutions.net/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.globalkeysolutions.net/companies/almac-sciences-limited/90ccdc83-facd-4798-aef2-460034d63adf

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