FDA Inspection
Equibal IncEquibal Inc – FDA Inspection, May 30, 2024
Record Details
This FDA Inspection record concerns Equibal Inc, with an inspection on May 30, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4cd3e046-3b45-41de-89cf-f7b7cd40c43c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1239888
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.84(d)(4)Microscopic Exam of Components
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Equibal Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 27, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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