Overview
- 8 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
6 Nov 2015
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Tajah L Blackburn, Rachel C Harrington
6 Nov 2015
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Tajah L Blackburn, Rachel C Harrington
6 Nov 2015
21 CFR 211.194(a)
Complete test data included in records
Cited by Tajah L Blackburn, Rachel C Harrington
6 Nov 2015
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Tajah L Blackburn, Rachel C Harrington
6 Nov 2015
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Tajah L Blackburn, Rachel C Harrington
Inspected site
WPWES Pharma Inc.Westminster, 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 | 2x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 8 observations
The source PDF, 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