Almac Pharma Services LLC
Form 483 issued December 7, 2017 · Audubon, Pennsylvania
- Inspection
- Nov 27 – Dec 7, 2017
- Investigators
- Christina K. Theodorou· Gayle S. Lawson
- Observations
- 5
- Pages
- 6
- FEI number
- 3000214934
In short: On December 7, 2017, FDA issued a Form 483 with 5 observations to Almac Pharma Services LLC in Audubon, Pennsylvania (FEI 3000214934) after an inspection that ran Nov 27 – Dec 7, 2017. The investigators were Christina K. Theodorou and Gayle S. Lawson. Most observations concern quality system and facilities & equipment.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Employees engaged in the manufacture, processing and packing of a drug product lack the education, training…
- 04
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
This inspection in context
Christina K. Theodorou
19 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) 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 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Almac Pharma Services LLC?
Christina K. Theodorou and Gayle S. Lawson are named on this Form 483, for the inspection of Nov 27 – Dec 7, 2017. Each investigator has a profile showing what they cite most.
When was Almac Pharma Services LLC inspected by FDA?
The inspection ran Nov 27 – Dec 7, 2017, and the Form 483 is dated December 7, 2017.
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.