# FDA 483 - Almac Pharma Services Limited - November 28, 2025

Source: https://www.keypedia.com/records/483/almac-pharma-services-limited/c3e5425c-086f-490a-9c69-be5017ee62ca

> FDA 483 for Almac Pharma Services Limited on November 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Almac Pharma Services Limited
- Inspection Date: 2025-11-28
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Almac Pharma Services Limited, a drug manufacturer in Craigavon, United Kingdom, was inspected and cited for significant deficiencies across its quality system. The inspection revealed failures in thoroughly investigating discrepancies and out-of-specification results, inadequate process controls and validation, insufficient equipment cleaning, and a lack of appropriate controls over computerized systems. Additionally, the firm was observed using unofficial records for GMP data.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

Company: https://www.keypedia.com/companies/almac-pharma-services-limited/cbb631be-ab57-4979-8135-9459efb00c73

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8