Patheon Manufacturing Services LLC
Form 483 issued August 4, 2022 · Greenville, North Carolina
- Inspection
- Jul 26 – Aug 4, 2022
- Investigators
- Claire M. Minden· Thomas R. Withers
- Observations
- 4
- Pages
- 4
- FEI number
- 1018495
In short: On August 4, 2022, FDA issued a Form 483 with 4 observations to Patheon Manufacturing Services LLC in Greenville, North Carolina (FEI 1018495) after an inspection that ran Jul 26 – Aug 4, 2022. The investigators were Claire M. Minden and Thomas R. Withers. 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 3 of 4 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 03
Investigations of an unexplained discrepancy did not extend to other drug products that may have been…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmPatheon Manufacturing Services LLC history
All 8 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 Patheon Manufacturing Services LLC?
FDA listed 4 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 Patheon Manufacturing Services LLC?
Claire M. Minden and Thomas R. Withers are named on this Form 483, for the inspection of Jul 26 – Aug 4, 2022. Each investigator has a profile showing what they cite most.
When was Patheon Manufacturing Services LLC inspected by FDA?
The inspection ran Jul 26 – Aug 4, 2022, and the Form 483 is dated August 4, 2022.
How do I get the full Form 483 for Patheon Manufacturing Services LLC?
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