Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-23.
At a glance
Inspections
10
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 May 2023 – 23 May 2023 | Human Drugs | 483 | View 483 → |
| 11 Sep 2019 – 22 Sep 2019 | Human Drugs | Clean | |
| 14 Jul 2019 – 25 Jul 2019 | Human Drugs | 483 | On file |
| 21 May 2017 – 25 May 2017 | Human Drugs | 483 | On file |
| 7 Jun 2015 – 15 Jun 2015 | Human Drugs | 483 | View 483 → |
| 10 Jul 2013 – 18 Jul 2013 | Human Drugs | Clean | |
| 26 Aug 2010 | Not recorded | 483 | View 483 → |
| 11 Jun 2009 | Not recorded | 483 | View 483 → |
| 28 Aug 2003 | Not recorded | Clean | |
| 25 Jul 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 May 2023
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Sean R Marcsisin, Michael Araneta
23 May 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sean R Marcsisin, Michael Araneta
23 May 2023
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Sean R Marcsisin, Michael Araneta
23 May 2023
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Sean R Marcsisin, Michael Araneta
Investigators
FDA investigators tied to this site in the record.
Sean R Marcsisin1 insp.
Michael Araneta1 insp.
Viviana Matta1 insp.
Noreen Muniz1 insp.
Dandan Wang1 insp.
Ruben C Ayala1 insp.
Meisha R Sampson1 insp.
Satheesh Thomas1 insp.
Meisha R Waters1 insp.
Steven M Weinman1 insp.
Larry K Austin1 insp.
Michael A Charles1 insp.
Kevin A Gonzalez1 insp.
Iraida Ortiz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.184(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Teva Pharmaceutical Industries Ltd.'s 6 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