Almac Pharma Services LLC
FDA inspection history in Audubon, Pennsylvania, 2015 to 2022
- 3
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two Form 483s, at Audubon, Pennsylvania.
- 2015The longest 483 on file: 6 observations over 4 pages at Audubon, Pennsylvania.
- 2022One Form 483, at Audubon, Pennsylvania.
Cited most
Across all Almac Pharma Services observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Almac Pharma Services file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Audubon, Pennsylvania
Three Form 483s · 2015 to 2022 · 13 observations
Latest: Form 483, Feb 3, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-02-03 | 483 Form 483 | Audubon, Pennsylvania | 2 | $99 |
| 2017-12-07 | 483 Form 483 | Audubon, Pennsylvania | 5 | $99 |
| 2015-06-25 | 483 Form 483 | Audubon, Pennsylvania | 6 | $99 |
Investigators on these documents
Brandy N. Lepage (1)Christina K. Theodorou (1)Gayle S. Lawson (1)Julianne C. McCullough (1)
FEI number 3000214934 · most recent document Feb 3, 2022
About Almac Pharma Services LLC
How many FDA Form 483s has Almac Pharma Services LLC received?
FDA Intel has 3 Form 483s on file for Almac Pharma Services LLC; the most recent is dated Feb 3, 2022.
When was Almac Pharma Services LLC last inspected by FDA?
The most recent FDA inspection document on file for Almac Pharma Services LLC is a Form 483 dated Feb 3, 2022, for the site in Audubon, Pennsylvania.
What did FDA cite at Almac Pharma Services LLC?
The regulations cited most in the observations on file for Almac Pharma Services LLC are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.