Overview
- 13 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-07-12.
At a glance
Inspections
13
Form 483s
9
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Jul 2022 – 12 Jul 2022 | Human Drugs | 483 | View 483 → |
| 1 Oct 2019 – 15 Oct 2019 | Human Drugs | 483 | View 483 → |
| 14 May 2018 – 31 May 2018 | Human Drugs | 483 | View 483 → |
| 8 Jun 2016 – 21 Jun 2016 | Human Drugs | 483 | On file |
| 25 Aug 2015 – 3 Sep 2015 | Human Drugs | 483 | View 483 → |
| 4 Aug 2014 – 11 Aug 2014 | Human Drugs | 483 | View 483 → |
| 8 May 2013 – 12 Jun 2013 | Human Drugs | 483 | View 483 → |
| 15 Jun 2011 | Not recorded | 483 | View 483 → |
| 4 Feb 2009 | Not recorded | 483 | On file |
| 31 Aug 2006 | Not recorded | Clean | |
| 14 Aug 2003 | Not recorded | Clean | |
| 31 Oct 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Jul 2022
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Marian E Ramirez, Angelica M Hernandez, Alan A Rivera
12 Jul 2022
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Marian E Ramirez, Angelica M Hernandez, Alan A Rivera
15 Oct 2019
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Jose F Velez, Jose R Flores-Veguilla
15 Oct 2019
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jose F Velez, Jose R Flores-Veguilla
15 Oct 2019
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Jose F Velez, Jose R Flores-Veguilla
Investigators
FDA investigators tied to this site in the record.
Libia M Lugo2 insp.
Marian E Ramirez1 insp.
Angelica M Hernandez1 insp.
Alan A Rivera1 insp.
Jose F Velez1 insp.
Jose R Flores-Veguilla1 insp.
Vilmary Negron Rodriguez1 insp.
Doan T Nguyen1 insp.
Jose E Melendez1 insp.
Cassandra L Abellard1 insp.
Jose A Cruz Gonzalez1 insp.
Miguel A Martinez1 insp.
Raquel Gonzalez Rivera1 insp.
Jose R Lopez1 insp.
Lourdes Andujar1 insp.
Laura E Garcia1 insp.
Brenda Rivera1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.130(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Patheon Puerto Rico, Inc.'s 9 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