FDA Inspection
Theochem Laboratories, Inc.Theochem Laboratories, Inc. – FDA Inspection, Oct 26, 2015
Record Details
This FDA Inspection record concerns Theochem Laboratories, Inc., with an inspection on October 26, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Theochem Laboratories, Inc.
- Inspection Date
- October 26, 2015
- Product Type
- Drugs
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ID · bec12f2d-8d43-48ec-ad5a-555e8aff331d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 947084
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 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 15, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 28, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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