Patheon Manufacturing Services LLC
Form 483 issued May 24, 2024 · Greenville, North Carolina
- Inspection
- May 15 – May 24, 2024
- Investigators
- Melanie M. Walker· Saundrea A. Munroe· Zhong Li
- Observations
- 4
- Pages
- 10
- FEI number
- 1018495
In short: On May 24, 2024, FDA issued a Form 483 with 4 observations to Patheon Manufacturing Services LLC in Greenville, North Carolina (FEI 1018495) after an inspection that ran May 15 – May 24, 2024. The investigators were Melanie M. Walker, Saundrea A. Munroe and Zhong Li. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Written records of investigations into do not include…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Melanie M. Walker
3 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Italy.
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 211.100
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 production and quality system. The opening words of each observation are shown on this page.
Who inspected Patheon Manufacturing Services LLC?
Melanie M. Walker, Saundrea A. Munroe and Zhong Li are named on this Form 483, for the inspection of May 15 – May 24, 2024. Each investigator has a profile showing what they cite most.
When was Patheon Manufacturing Services LLC inspected by FDA?
The inspection ran May 15 – May 24, 2024, and the Form 483 is dated May 24, 2024.
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.