Overview
- 23 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-08-20.
At a glance
Inspections
23
Form 483s
9
EIRs
8
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2021 – 20 Aug 2021 | Human Drugs | 483 | View 483 → |
| 26 Aug 2019 – 30 Aug 2019 | Human Drugs | 483 | View 483 → |
| 11 Jan 2019 – 18 Jan 2019 | Human Drugs | 483 | View 483 → |
| 13 Dec 2016 – 19 Dec 2016 | Human Drugs | Clean | |
| 11 Apr 2016 – 29 Jul 2016 | Human Drugs | 483 | On file |
| 2 Jun 2014 – 6 Jun 2014 | Human Drugs | Clean | |
| 29 May 2013 – 4 Jun 2013 | Human Drugs | 483 | View 483 → |
| 10 Aug 2012 | Not recorded | Clean | |
| 24 Apr 2012 | Not recorded | 483 | View 483 → |
| 14 May 2010 | Not recorded | 483 | View 483 → |
| 1 Feb 2010 | Not recorded | Clean | |
| 24 Jul 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Aug 2021
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Bryan A Galvez, Walden H Lee, Amir Alavi, Sangeeta M Khurana, Thomas J Arista, Santiago Gallardo Johnson
20 Aug 2021
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Bryan A Galvez, Walden H Lee, Amir Alavi, Sangeeta M Khurana, Thomas J Arista, Santiago Gallardo Johnson
20 Aug 2021
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Bryan A Galvez, Walden H Lee, Amir Alavi, Sangeeta M Khurana, Thomas J Arista, Santiago Gallardo Johnson
20 Aug 2021
21 CFR 211.165(a)
Testing and release for distribution
Cited by Bryan A Galvez, Walden H Lee, Amir Alavi, Sangeeta M Khurana, Thomas J Arista, Santiago Gallardo Johnson
20 Aug 2021
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Bryan A Galvez, Walden H Lee, Amir Alavi, Sangeeta M Khurana, Thomas J Arista, Santiago Gallardo Johnson
Investigators
FDA investigators tied to this site in the record.
Caryn M Mcnab4 insp.
Carla J Lundi3 insp.
Jennifer M Gogley3 insp.
Walden H Lee2 insp.
Amir Alavi2 insp.
Sangeeta M Khurana2 insp.
Thomas J Arista2 insp.
Marcus F Yambot2 insp.
Bichsa T Tran2 insp.
Virgilio F Pacio2 insp.
Binh T Nguyen2 insp.
Joey V Quitania2 insp.
Bryan A Galvez1 insp.
Santiago Gallardo Johnson1 insp.
Linda F Murphy1 insp.
Alan P Kurtzberg1 insp.
Adam R Cooke1 insp.
Amanda L Fyles1 insp.
Jeffery A Johnson1 insp.
Sparky L Bartee1 insp.
Gregory A Berg1 insp.
Shannon B Ruelle1 insp.
Comyar Shoghi1 insp.
Kim L Thomas Cruse1 insp.
John A Gonzalez1 insp.
Dyana K Stone1 insp.
Kham Phommachanh1 insp.
Katherine E Jacobitz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(c) | 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)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.60(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Teva Parenteral Medicines 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