Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-08-01.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Jul 2019 – 1 Aug 2019 | Human Drugs | 483 | On file |
| 16 Jun 2015 – 22 Jun 2015 | Human Drugs | 483 | View 483 → |
| 13 Oct 2013 – 17 Oct 2013 | Human Drugs | Clean | |
| 19 Jun 2011 | Not recorded | Clean | |
| 16 Sep 2010 | Not recorded | WL | On file |
| 25 Sep 2008 | Not recorded | 483 | On file |
| 9 Nov 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jun 2015
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Meisha R Sampson, Satheesh Thomas, Meisha R Waters
22 Jun 2015
21 CFR 211.110(a)
Written in-process control procedures
Cited by Meisha R Sampson, Satheesh Thomas, Meisha R Waters
22 Jun 2015
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Meisha R Sampson, Satheesh Thomas, Meisha R Waters
22 Jun 2015
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Meisha R Sampson, Satheesh Thomas, Meisha R Waters
22 Jun 2015
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Meisha R Sampson, Satheesh Thomas, Meisha R Waters
Investigators
FDA investigators tied to this site in the record.
Leonard H Lavi2 insp.
Noreen Muniz1 insp.
Dandan Wang1 insp.
Meisha R Sampson1 insp.
Satheesh Thomas1 insp.
Meisha R Waters1 insp.
Edwin Melendez1 insp.
Ernest Bizjak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Teva Pharmaceutical Industries' 4 Form 483s
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