Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-09-01.
At a glance
Inspections
6
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Sep 2011 | Not recorded | 483 | View 483 → |
| 19 Mar 2009 | Not recorded | 483 | On file |
| 23 May 2007 | Not recorded | Clean | |
| 2 May 2005 | Not recorded | Clean | |
| 14 Dec 2001 | Not recorded | Clean | |
| 6 Dec 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Sep 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose E Melendez, Ramon A Hernandez
1 Sep 2011
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Jose E Melendez, Ramon A Hernandez
1 Sep 2011
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jose E Melendez, Ramon A Hernandez
1 Sep 2011
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jose E Melendez, Ramon A Hernandez
1 Sep 2011
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Jose E Melendez, Ramon A Hernandez
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(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 Pharmaceuticals LLC's 2 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