Almac Pharma Services LLC
Form 483 issued February 3, 2022 · Audubon, Pennsylvania
- Inspection
- Jan 19 – Feb 3, 2022
- Investigator
- Brandy N. Lepage
- Observations
- 2
- Pages
- 4
- FEI number
- 3000214934
In short: On February 3, 2022, FDA issued a Form 483 with 2 observations to Almac Pharma Services LLC in Audubon, Pennsylvania (FEI 3000214934) after an inspection that ran Jan 19 – Feb 3, 2022. The investigator was Brandy N. Lepage. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.58 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Deviations from written production and process control…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAlmac Pharma Services LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Almac Pharma Services LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Almac Pharma Services LLC?
Brandy N. Lepage is named on this Form 483, for the inspection of Jan 19 – Feb 3, 2022. Each investigator has a profile showing what they cite most.
When was Almac Pharma Services LLC inspected by FDA?
The inspection ran Jan 19 – Feb 3, 2022, and the Form 483 is dated February 3, 2022.
How do I get the full Form 483 for Almac Pharma Services LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.