Overview
- 12 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
7 Jun 2017
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Dien N Nguyen, Nealie C Newberger, Christopher Janik
7 Jun 2017
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Dien N Nguyen, Nealie C Newberger, Christopher Janik
7 Jun 2017
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Dien N Nguyen, Nealie C Newberger, Christopher Janik
7 Jun 2017
21 CFR 211.165(e)
Test methods
Cited by Dien N Nguyen, Nealie C Newberger, Christopher Janik
7 Jun 2017
21 CFR 211.165(e)
Test methods
Cited by Dien N Nguyen, Nealie C Newberger, Christopher Janik
Inspected site
PIPfizer, Inc.Groton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 12 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere