FDA Inspection
Sina Health IncSina Health Inc – FDA Inspection, Apr 25, 2017
Record Details
This FDA Inspection record concerns Sina Health Inc, with an inspection on April 25, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c6b77162-4150-4b88-a69f-30c3e507beb5
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1010231
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 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 |
|---|---|---|---|
| January 13, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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