FDA Inspection
Dr. Sabharwals Wound CareDr. Sabharwals Wound Care – FDA Inspection, Jul 12, 2019
Record Details
This FDA Inspection record concerns Dr. Sabharwals Wound Care, with an inspection on July 12, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cf066921-64e8-4990-9ed5-44c7e0f88d93
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096346
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(b)(7)Documentation of Actual Yield and Theoretical Yield
- 21 CFR 211.188(b)(3)Identification of Components and In-Process Materials
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Dr. Sabharwals Wound Care
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2025 | Not classified | Office of Inspections and Investigations |
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