FDA Inspection
Coretex Products Inc.Coretex Products Inc. – FDA Inspection, Apr 28, 2021
Record Details
This FDA Inspection record concerns Coretex Products Inc., with an inspection on April 28, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Coretex Products Inc.
- Inspection Date
- April 28, 2021
- Product Type
- Drugs
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ID · 6ced277a-9659-42c2-9b79-9e458d8ac688
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1140945
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Coretex Products Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2026 | Not classified | New Orleans District Office | Drug Quality Assurance |
| November 2, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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