FDA Inspection
Theochem Laboratories, Inc.Theochem Laboratories, Inc. – FDA Inspection, Oct 15, 2012
Record Details
This FDA Inspection record concerns Theochem Laboratories, Inc., with an inspection on October 15, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Theochem Laboratories, Inc.
- Inspection Date
- October 15, 2012
- Product Type
- Drugs
View Company Profile
ID · 71699c9c-de0e-48a4-a9f7-330febfe27bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803299
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(a)Approve or reject components, products
- 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 |
| January 28, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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