Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
12 Apr 2023
21 CFR 211.166(a)
Lack of written stability program
Cited by Khoa Nathan V Tran, Lillian S Wu, Rowena S Nguyen
12 Apr 2023
21 CFR 211.180(e)
Records reviewed annually
Cited by Khoa Nathan V Tran, Lillian S Wu, Rowena S Nguyen
12 Apr 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Khoa Nathan V Tran, Lillian S Wu, Rowena S Nguyen
12 Apr 2023
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Khoa Nathan V Tran, Lillian S Wu, Rowena S Nguyen
12 Apr 2023
21 CFR 211.63
Equipment Design, Size and Location
Cited by Khoa Nathan V Tran, Lillian S Wu, Rowena S Nguyen
Inspected site
CDCOLONIAL DAMES CO LTDCommerce, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Source document
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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