Patheon Pharmaceuticals Inc.
FDA inspection history in Cincinnati, Ohio, 2015 to 2018
- 3
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2016: one Form 483; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Three Form 483s, at Cincinnati, Ohio.
- 2018The longest 483 on file: 6 observations over 8 pages at Cincinnati, Ohio.
Cited most
Across all Patheon Pharmaceuticals observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Patheon Pharmaceuticals file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Cincinnati, Ohio
Three Form 483s · 2015 to 2018 · 11 observations
Latest: Form 483, Feb 14, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-02-14 | 483 Form 483 | Cincinnati, Ohio | 6 | $99 |
| 2016-03-11 | 483 Form 483 | Cincinnati, Ohio | 2 | $99 |
| 2015-08-21 | 483 Form 483 | Cincinnati, Ohio | 3 | $99 |
Investigators on these documents
Christopher T. Middendorf (1)Lauren N. Smith (1)Nicholas L. Paulin (1)
FEI number 1510437 · most recent document Feb 14, 2018
About Patheon Pharmaceuticals Inc.
How many FDA Form 483s has Patheon Pharmaceuticals Inc. received?
FDA Intel has 3 Form 483s on file for Patheon Pharmaceuticals Inc.; the most recent is dated Feb 14, 2018.
When was Patheon Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Patheon Pharmaceuticals Inc. is a Form 483 dated Feb 14, 2018, for the site in Cincinnati, Ohio.
What did FDA cite at Patheon Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Patheon Pharmaceuticals Inc. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times.