FDA Inspection
COLONIAL DAMES CO LTDCOLONIAL DAMES CO LTD – FDA Inspection, Apr 12, 2023
Record Details
This FDA Inspection record concerns COLONIAL DAMES CO LTD, with an inspection on April 12, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · beb800a0-9ea3-4c01-ba6e-457eb394a750
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1203628
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of COLONIAL DAMES CO LTD
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2024 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| February 23, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 29, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 25, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 20, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for COLONIAL DAMES CO LTD
- FDA Inspection 1252829 - 2024-09-12
- FDA Inspection 1232599 - 2024-02-23
- FDA Inspection 1141007 - 2021-04-29
- FDA Inspection 933385 - 2015-06-25
- FDA Inspection 773333 - 2012-03-20
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