FDA Inspection
Theochem Laboratories, Inc.Theochem Laboratories, Inc. – FDA Inspection, Jan 28, 2010
Record Details
This FDA Inspection record concerns Theochem Laboratories, Inc., with an inspection on January 28, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Theochem Laboratories, Inc.
- Inspection Date
- January 28, 2010
- Product Type
- Drugs
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ID · d5b62911-cc3a-49f9-af32-d5e9905623de
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 639069
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Theochem Laboratories, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 15, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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