FDA Inspection
Sina Health IncSina Health Inc – FDA Inspection, Jan 13, 2023
Record Details
This FDA Inspection record concerns Sina Health Inc, with an inspection on January 13, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 8349cb8e-a82c-4f18-a780-d8a3a1996d5c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196912
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.125(b)Examination of issued labels
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.125(b)Examination of issued labels
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Sina Health Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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