Patheon Biologics LLC
Form 483 issued November 20, 2024 · Saint Louis, Missouri
- Inspection
- Nov 13 – Nov 20, 2024
- Investigators
- Ogechi C. Nna· Tyler Peterson
- Observations
- 2
- Pages
- 3
- FEI number
- 3003418999
In short: On November 20, 2024, FDA issued a Form 483 with 2 observations to Patheon Biologics LLC in Saint Louis, Missouri (FEI 3003418999) after an inspection that ran Nov 13 – Nov 20, 2024. The investigators were Ogechi C. Nna and Tyler Peterson. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
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 whether or not the…
- 02
Procedures describing laboratory testing of materials are…
This inspection in context
Ogechi C. Nna
7 documents · 2023–2026
Cites 211.67(a) (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmPatheon Biologics 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 Biologics LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Patheon Biologics LLC?
Ogechi C. Nna and Tyler Peterson are named on this Form 483, for the inspection of Nov 13 – Nov 20, 2024. Each investigator has a profile showing what they cite most.
When was Patheon Biologics LLC inspected by FDA?
The inspection ran Nov 13 – Nov 20, 2024, and the Form 483 is dated November 20, 2024.
How do I get the full Form 483 for Patheon Biologics 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.