Almac Pharma Services LLC
Form 483 issued June 25, 2015 · Audubon, Pennsylvania
- Inspection
- Jun 18 – Jun 25, 2015
- Investigator
- Julianne C. McCullough
- Observations
- 6
- Pages
- 4
- FEI number
- 3000214934
In short: On June 25, 2015, FDA issued a Form 483 with 6 observations to Almac Pharma Services LLC in Audubon, Pennsylvania (FEI 3000214934) after an inspection that ran Jun 18 – Jun 25, 2015. The investigator was Julianne C. McCullough. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 5 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
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 and the failure of a batch…
- 02
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Julianne C. McCullough
4 documents · 2010–2019
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 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Almac Pharma Services LLC?
Julianne C. McCullough is named on this Form 483, for the inspection of Jun 18 – Jun 25, 2015. Each investigator has a profile showing what they cite most.
When was Almac Pharma Services LLC inspected by FDA?
The inspection ran Jun 18 – Jun 25, 2015, and the Form 483 is dated June 25, 2015.
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.