Patheon Biologics LLC
FDA inspection history in Saint Louis, Missouri, 2018 to 2024
- 8
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483; 2022: one Form 483; 2023: four Form 483s; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Saint Louis, Missouri.
- 2018The longest 483 on file: 9 observations over 4 pages at Saint Louis, Missouri.
- 2022–24Six Form 483s, at Saint Louis, Missouri.
Cited most
Across all Patheon Biologics observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.160General requirements5
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.58Maintenance4
The complete Patheon Biologics file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Saint Louis, Missouri
Eight Form 483s · 2018 to 2024 · 41 observations
Latest: Form 483, Nov 20, 2024 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-20 | 483 Form 483 | Saint Louis, Missouri | 2 | $99 |
| 2023-12-08 | 483 Form 483 | Saint Louis, Missouri | 3 | $99 |
| 2023-11-10 | 483 Form 483 | Saint Louis, Missouri | 6 | $99 |
| 2023-03-02 | 483 Form 483 | Saint Louis, Missouri | 4 | $99 |
| 2023-01-24 | 483 Form 483 | Saint Louis, Missouri | 8 | $99 |
| 2022-05-02 | 483 Form 483 | Saint Louis, Missouri | 3 | $99 |
| 2019-08-02 | 483 Form 483 | Saint Louis, Missouri | 6 | $99 |
| 2018-10-09 | 483 Form 483 | Saint Louis, Missouri | 9 | $99 |
Investigators on these documents
Brian A. Roelofs (1)Ee Joslyn Brunelle (1)Joslyn Brunelle (1)Michele L. Glendenning (1)Monica E. Murie (1)Ogechi C. Nna (1)Tyler Peterson (1)
FEI number 3003418999 · most recent document Nov 20, 2024
About Patheon Biologics LLC
How many FDA Form 483s has Patheon Biologics LLC received?
FDA Intel has 8 Form 483s on file for Patheon Biologics LLC; the most recent is dated Nov 20, 2024.
When was Patheon Biologics LLC last inspected by FDA?
The most recent FDA inspection document on file for Patheon Biologics LLC is a Form 483 dated Nov 20, 2024, for the site in Saint Louis, Missouri.
What did FDA cite at Patheon Biologics LLC?
The regulations cited most in the observations on file for Patheon Biologics LLC are 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.160 (General requirements), 5 times; 21 CFR 211.100 (Written procedures; deviations), 4 times.