Overview
- 10 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-03-28.
At a glance
Inspections
10
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2013 – 28 Mar 2013 | Human Drugs | 483 | View 483 → |
| 4 May 2010 | Not recorded | 483 | View 483 → |
| 8 Apr 2009 | Not recorded | 483 | View 483 → |
| 29 Oct 2007 | Not recorded | Clean | |
| 28 Sep 2006 | Not recorded | Clean | |
| 8 Sep 2004 | Not recorded | Clean | |
| 24 Jan 2003 | Not recorded | Clean | |
| 17 Dec 2002 | Not recorded | Clean | |
| 7 Dec 2001 | Not recorded | Clean | |
| 1 May 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Mar 2013
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Rebecca Parrilla
28 Mar 2013
21 CFR 211.166(a)
Results not used for expiration dates, storage cond.
Cited by Rebecca Parrilla
4 May 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose A Moreno, Jose R Lopez
4 May 2010
21 CFR 211.65(a)
Equipment construction - reactive surfaces
Cited by Jose A Moreno, Jose R Lopez
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Patheon Puerto Rico Inc.'s 3 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat