Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-07-22.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Jul 2022 – 22 Jul 2022 | Human Drugs | Clean | |
| 10 Aug 2015 – 26 Aug 2015 | Human Drugs | 483 | View 483 → |
| 15 Oct 2012 | Not recorded | 483 | View 483 → |
| 6 Jun 2012 | Not recorded | Clean | |
| 10 Aug 2009 | Not recorded | WL | On file |
| 18 Apr 2006 | Not recorded | Clean | |
| 29 Jul 2004 | Not recorded | Clean | |
| 7 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Aug 2015
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Michael Serrano, Helen B Ricalde, Charisse K Green
26 Aug 2015
21 CFR 314.80(i)
Failure to maintain records
Cited by Michael Serrano, Helen B Ricalde, Charisse K Green
26 Aug 2015
21 CFR 314.80(j)
Failure to maintain records
Cited by Michael Serrano, Helen B Ricalde, Charisse K Green
15 Oct 2012
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Alice S Tsao, Demitria J Xiradakis, Charisse K Green
15 Oct 2012
21 CFR 314.80(b)
Failure to review ADE information
Cited by Alice S Tsao, Demitria J Xiradakis, Charisse K Green
Investigators
FDA investigators tied to this site in the record.
Charisse K Green2 insp.
Demitria J Xiradakis2 insp.
Byungja E Marciante1 insp.
Kerun Hardeo1 insp.
Michael Serrano1 insp.
Helen B Ricalde1 insp.
Alice S Tsao1 insp.
Iram R Hassan1 insp.
Satheesh Thomas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.80(c)(1)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 314.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pfizer Inc.'s 3 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