Overview
- 5 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.
10 Nov 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Margaret M Annes, Dorothy P Kramer, Christopher N Tran
10 Nov 2022
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Margaret M Annes, Dorothy P Kramer, Christopher N Tran
10 Nov 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Margaret M Annes, Dorothy P Kramer, Christopher N Tran
10 Nov 2022
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Margaret M Annes, Dorothy P Kramer, Christopher N Tran
10 Nov 2022
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Margaret M Annes, Dorothy P Kramer, Christopher N Tran
Inspected site
PPPD-Rx Pharmaceuticals Inc.Oklahoma City, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 5 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