Patheon Biologics LLC
Form 483 issued May 2, 2022 · Saint Louis, Missouri
- Inspection
- May 2, 2022
- Investigator
- Brian A. Roelofs
- Observations
- 3
- Pages
- 2
- FEI number
- 3003418999
In short: On May 2, 2022, FDA issued a Form 483 with 3 observations to Patheon Biologics LLC in Saint Louis, Missouri (FEI 3003418999) after an inspection that ran May 2, 2022. The investigator was Brian A. Roelofs. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
2 of 3 observations on this 483 concern materials.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Temperature controlled storage areas for cGMP materials are not qualified…
- 02
Labeling of cGMP materials…
- 03
Documentation of Batch Record and SOPs do not adequately describe…
This inspection in context
Brian A. Roelofs
1 document · 2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Missouri.
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 211.142
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 materials and production. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected Patheon Biologics LLC?
Brian A. Roelofs is named on this Form 483, for the inspection of May 2, 2022. Each investigator has a profile showing what they cite most.
When was Patheon Biologics LLC inspected by FDA?
The inspection ran May 2, 2022, and the Form 483 is dated May 2, 2022.
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.