FDA Inspection
BioChemics, Inc.BioChemics, Inc. – FDA Inspection, Dec 22, 2015
Record Details
This FDA Inspection record concerns BioChemics, Inc., with an inspection on December 22, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- BioChemics, Inc.
- Inspection Date
- December 22, 2015
- Product Type
- Drugs
View Company Profile
ID · e7290c1b-0f67-4ed0-b706-779fd182c070
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955852
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BioChemics, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for BioChemics, Inc.
- FDA Inspection 659986 - 2010-05-03
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