FDA Inspection
Almac Pharma Services LLCAlmac Pharma Services LLC – FDA Inspection, Dec 7, 2017
Record Details
This FDA Inspection record concerns Almac Pharma Services LLC, with an inspection on December 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5a2f3f6e-a291-496b-9601-d271d2b02449
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1034114
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Almac Pharma Services LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | VAI | Philadelphia District Office | Drug Quality Assurance |
| September 10, 2019 | Not classified | Philadelphia District Office | |
| June 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 10, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Almac Pharma Services LLC
- FDA Inspection 1279450 - 2025-08-22
- FDA Inspection 1109743 - 2019-09-10
- FDA Inspection 935536 - 2015-06-25
- FDA Inspection 813617 - 2013-01-10
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