FDA Inspection
Colgin, IncColgin, Inc – FDA Inspection, Sep 21, 2023
Record Details
This FDA Inspection record concerns Colgin, Inc, with an inspection on September 21, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0a93866c-6ba6-4636-9ed2-dbd290ba3259
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1219446
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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Other FDA inspections of Colgin, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2026 | NAI | Foodborne Biological Hazards | |
| January 8, 2019 | Not classified | Dallas District Office | |
| January 5, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 21, 2010 | NAI | Center for Food Safety and Applied Nutrition | Food and Color Additives Petition Review |
Other documents for Colgin, Inc
- FDA Inspection 1307754 - 2026-03-04
- FDA Inspection 1076355 - 2019-01-08
- FDA Inspection 953974 - 2016-01-05
- FDA Inspection 657667 - 2010-04-21
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