Patheon Manufacturing Services LLC
Form 483 issued August 14, 2020 · Greenville, North Carolina
- Inspection
- Aug 10 – Aug 14, 2020
- Investigators
- Viviana Matta· Yun Wu
- Observations
- 2
- Pages
- 4
- FEI number
- 1018495
In short: On August 14, 2020, FDA issued a Form 483 with 2 observations to Patheon Manufacturing Services LLC in Greenville, North Carolina (FEI 1018495) after an inspection that ran Aug 10 – Aug 14, 2020. The investigators were Viviana Matta and Yun Wu. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.22 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities of the quality control unit are not in…
- 02
The system for cleaning and disinfecting the room and equipment to produce aseptic…
This inspection in context
Viviana Matta
17 documents · 2012–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Manufacturing Services LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Patheon Manufacturing Services LLC?
Viviana Matta and Yun Wu are named on this Form 483, for the inspection of Aug 10 – Aug 14, 2020. Each investigator has a profile showing what they cite most.
When was Patheon Manufacturing Services LLC inspected by FDA?
The inspection ran Aug 10 – Aug 14, 2020, and the Form 483 is dated August 14, 2020.
How do I get the full Form 483 for Patheon Manufacturing 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.