FDA Inspection
Biomedica Biological Testing LaboratoriesBiomedica Biological Testing Laboratories – FDA Inspection, Jan 24, 2014
Record Details
This FDA Inspection record concerns Biomedica Biological Testing Laboratories, with an inspection on January 24, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 24, 2014
- Product Type
- Drugs
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ID · f382ca0a-d066-4dc6-9c64-0fd214b0866d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 863534
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Biomedica Biological Testing Laboratories
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Biomedica Biological Testing Laboratories
- FDA Inspection 970175 - 2016-05-18
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