Warning letter
Colonial Dames Company, Ltd: warning letter of Dec 5, 2023
FDA warning letter 659151 · Division of Pharmaceutical Quality Operations IV
Key facts
| Reference number | 659151 |
|---|---|
| Company | Colonial Dames Company, Ltd |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 5, 2023 |
| Posted date | Dec 26, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations IV |
| Product type | Drugs |
| CFR sections cited | 201.128, 207, 211.22, 211.34, 211.63, 330, 201.66(b)(2), 211.67(a), 211.100(a), 211.166(a), 310.502(a)(14), 207.29(b) and 1 more |
| Inspection city | Commerce |
| Inspection ZIP | 90040 |
| Inspection start date | Apr 4, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: