FDA Inspection
B & E Medical Equipment, IncB & E Medical Equipment, Inc – FDA Inspection, Sep 14, 2012
Record Details
This FDA Inspection record concerns B & E Medical Equipment, Inc, with an inspection on September 14, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- B & E Medical Equipment, Inc
- Inspection Date
- September 14, 2012
- Product Type
- Drugs
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ID · ad69906c-e285-4635-bae4-61a93807af48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 799314
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of B & E Medical Equipment, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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