Drug factory · FDA FEI 3000214934
Almac Pharma Services LLC
2661 Audubon Road, Audubon, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 22, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2013: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Elexacaftor and Ivacaftor and Tezacaftor | Packages it and labels it | Vertex Pharmaceuticals Incorporated | 51167-445, 51167-446 |
| Rilonacept | Packages it | Kiniksa Pharmaceuticals (UK), Ltd. | 73604-914 |
| Teplizumab | Packages it and labels it | Provention Bio, Inc. | 73650-316 |
| Vestronidase Alfa | Makes it, packages it and labels it | Ultragenyx Pharmaceutical Inc. | 69794-001 |
| Zanidatamab | Packages it and labels it | Jazz Pharmaceuticals, Inc. | 68727-950 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 22, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Dec 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 25, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 10, 2013 | No problems found | 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.
Aug 22, 2025 inspection
- Rejected in-process materials not quarantined 21 CFR 211.110(d)
Rejected in-process materials are not controlled under a quarantine system to prevent their use in manufacturing or processing operations for which they are unsuitable. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the receipt of drug product containers.
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.