Patheon Biologics LLC
Form 483 issued December 8, 2023 · Saint Louis, Missouri
- Inspection
- Dec 6 – Dec 8, 2023
- Investigators
- Michele L. Glendenning· Monica E. Murie
- Observations
- 3
- Pages
- 3
- FEI number
- 3003418999
In short: On December 8, 2023, FDA issued a Form 483 with 3 observations to Patheon Biologics LLC in Saint Louis, Missouri (FEI 3003418999) after an inspection that ran Dec 6 – Dec 8, 2023. The investigators were Michele L. Glendenning and Monica E. Murie. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations are not thoroughly…
- 02
Appropriate environmental controls are not established to ensure adequate monitoring of the facility and production equipment…
- 03
Buildings used in the manufacture of drug substances are not properly repaired and maintained…
This inspection in context
Michele L. Glendenning
18 documents · 2018–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Illinois.
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 3 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Patheon Biologics LLC?
Michele L. Glendenning and Monica E. Murie are named on this Form 483, for the inspection of Dec 6 – Dec 8, 2023. Each investigator has a profile showing what they cite most.
When was Patheon Biologics LLC inspected by FDA?
The inspection ran Dec 6 – Dec 8, 2023, and the Form 483 is dated December 8, 2023.
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.