Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-23.
At a glance
Inspections
14
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Nov 2022 – 23 Nov 2022 | Human Drugs | 483 | On file |
| 31 Jul 2018 – 10 Aug 2018 | Human Drugs | Clean | |
| 13 Feb 2017 – 3 Mar 2017 | Human Drugs | 483 | On file |
| 18 Feb 2015 – 6 Mar 2015 | Human Drugs | 483 | On file |
| 13 Mar 2013 – 11 Apr 2013 | Human Drugs | 483 | On file |
| 13 Sep 2012 | Not recorded | Clean | |
| 29 Jul 2011 | Not recorded | WL | On file |
| 29 Dec 2009 | Not recorded | 483 | On file |
| 15 Sep 2008 | Not recorded | 483 | On file |
| 2 Dec 2005 | Not recorded | Clean | |
| 20 Jul 2004 | Not recorded | Clean | |
| 14 Mar 2003 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Mar 2017
21 CFR 211.100(b)
SOPs not followed / documented
Cited by German Rivera, Youmin Wang
3 Mar 2017
21 CFR 211.100(b)
SOPs not followed / documented
Cited by German Rivera, Youmin Wang
3 Mar 2017
21 CFR 211.100(b)
SOPs not followed / documented
Cited by German Rivera, Youmin Wang
3 Mar 2017
21 CFR 211.100(b)
SOPs not followed / documented
Cited by German Rivera, Youmin Wang
3 Mar 2017
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by German Rivera, Youmin Wang
Investigators
FDA investigators tied to this site in the record.
Libia M Lugo3 insp.
Jose E Melendez2 insp.
Marian E Ramirez1 insp.
German Rivera1 insp.
Youmin Wang1 insp.
Ariel Cruz Figueroa1 insp.
Cassandra L Abellard1 insp.
Rebecca Parrilla1 insp.
Jorge L Lajara1 insp.
Adalberto Cajigas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Teva Puerto Rico LLC's 7 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