Drug factory · FDA FEI 3004444888
Almac Pharma Services Limited
Seagoe Industrial Estate, Craigavon, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Nov 28, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 4 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Sep 16, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 6, 2019 | No problems found | Drug Quality Assurance | — |
| Jun 23, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 22, 2015 | No problems found | Drug Quality Assurance | — |
| Apr 26, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 27, 2011 | No problems found | Drug Quality Assurance | — |
| May 15, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 28, 2025 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; label; manufacture; pack.