FDA Inspection
Coretex Products Inc.Coretex Products Inc. – FDA Inspection, Nov 2, 2015
Record Details
This FDA Inspection record concerns Coretex Products Inc., with an inspection on November 2, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Coretex Products Inc.
- Inspection Date
- November 2, 2015
- Product Type
- Drugs
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ID · 96d8eddb-587d-4857-8c19-e53e4307ab33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946394
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(3)Testing Containers & Closures Conformity with Specs
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192Written record of investigation incomplete
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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 |
| April 28, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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