FDA Inspection
Equibal IncEquibal Inc – FDA Inspection, May 27, 2016
Record Details
This FDA Inspection record concerns Equibal Inc, with an inspection on May 27, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Equibal Inc
- Inspection Date
- May 27, 2016
- Product Type
- Drugs
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ID · 7732a06a-4e15-440f-82be-1bf972919bbb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 972172
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.198(b)Maintenance of Complaint File
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.182Personnel dating/signing equipment log
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Showing 10 of 11 citations.
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Other FDA inspections of Equibal Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 30, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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