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

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.