Overview
- 6 public-safe observations are available for this inspection.
- 6 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 Oct 2022
21 CFR 211.100(a)
Approval and review of procedures
Cited by Bijoy Panicker, Brandy N Lepage
6 Oct 2022
21 CFR 211.103
Actual vs. theoretical yields not determined
Cited by Bijoy Panicker, Brandy N Lepage
6 Oct 2022
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Bijoy Panicker, Brandy N Lepage
6 Oct 2022
21 CFR 211.42(c)(5)
Mfg / Processing Operations Area
Cited by Bijoy Panicker, Brandy N Lepage
6 Oct 2022
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Bijoy Panicker, Brandy N Lepage
Inspected site
CPChartwell Pharmaceuticals Carmel, LLC.Carmel, 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 | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 6 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