Patheon Puerto Rico, Inc.
FDA inspection history in Manati, Puerto Rico, 2014 to 2022
- 6
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2015: one Form 483; 2016: one Form 483; 2018: one Form 483; 2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–19Five Form 483s, at Manati, Puerto Rico.
- 2014The longest 483 on file: 6 observations over 4 pages at Manati, Puerto Rico.
- 2022One Form 483, at Manati, Puerto Rico.
Cited most
Across all Patheon Puerto Rico observations on file
- 21 CFR 211.100(a)Written procedures; deviations3
- 21 CFR 211.192Production record review3
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.80General requirements2
The complete Patheon Puerto Rico file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Manati, Puerto Rico
Six Form 483s · 2014 to 2022 · 19 observations
Latest: Form 483, Jul 12, 2022 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-12 | 483 Form 483 | Manati, Puerto Rico | 2 | $99 |
| 2019-10-15 | 483 Form 483 | Manati, Puerto Rico | 2 | $99 |
| 2018-05-31 | 483 Form 483 | Manati, Puerto Rico | 3 | $99 |
| 2016-06-21 | 483 Form 483 | Manati, Puerto Rico | 1 | $99 |
| 2015-09-03 | 483 Form 483 | Manati, Puerto Rico | 5 | $99 |
| 2014-08-11 | 483 Form 483 | Manati, Puerto Rico | 6 | $99 |
Investigators on these documents
Angelica M. Hernandez (1)Cassandra L. Abellard (1)Doan T. Nguyen (1)Jose A. Cruz-Gonzalez (1)Jose E. Melendez (1)Libia M. Lugo (1)Miguel A. Martinez (1)Vilmary Negron Rodriguez (1)
FEI number 3003113148 · most recent document Jul 12, 2022
About Patheon Puerto Rico, Inc.
How many FDA Form 483s has Patheon Puerto Rico, Inc. received?
FDA Intel has 6 Form 483s on file for Patheon Puerto Rico, Inc.; the most recent is dated Jul 12, 2022.
When was Patheon Puerto Rico, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Patheon Puerto Rico, Inc. is a Form 483 dated Jul 12, 2022, for the site in Manati, Puerto Rico.
What did FDA cite at Patheon Puerto Rico, Inc.?
The regulations cited most in the observations on file for Patheon Puerto Rico, Inc. are 21 CFR 211.100(a) (Written procedures; deviations), 3 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.160(b) (General requirements), 2 times.