Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-18.
At a glance
Inspections
7
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Oct 2022 – 18 Oct 2022 | Human Drugs | 483 | View 483 → |
| 29 Aug 2019 – 6 Sep 2019 | Human Drugs | WL | On file |
| 10 Sep 2018 – 21 Sep 2018 | Human Drugs | 483 | View 483 → |
| 9 Mar 2017 – 17 Mar 2017 | Human Drugs | 483 | On file |
| 31 Aug 2015 – 8 Sep 2015 | Human Drugs | 483 | View 483 → |
| 16 Feb 2015 – 25 Feb 2015 | Human Drugs | 483 | On file |
| 18 Mar 2014 – 22 Mar 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Sep 2015
21 CFR 211.110(c)
In-process materials characteristics testing
Cited by Angela E Glenn, Santos E Camara, Daniel J Roberts
Investigators
FDA investigators tied to this site in the record.
Yasamin Ameri1 insp.
Junho Pak1 insp.
Jose E Melendez1 insp.
Samina S Khan1 insp.
Justin A Boyd1 insp.
Toyin B Oladimeji1 insp.
Angela E Glenn1 insp.
Santos E Camara1 insp.
Daniel J Roberts1 insp.
Thomas J Arista1 insp.
Michael R Klapal1 insp.
Steven M Weinman1 insp.
Peter E Baker1 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 | 4x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pfizer Healthcare India Private Limited'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