FDA Inspection 1096346 — Dr. Sabharwals Wound Care
The FDA completed an inspection of Dr. Sabharwals Wound Care on July 12, 2019 in Buranwala. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 12, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Buranwala (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2015 | 21 CFR 211.188(b)(3) | Identification of Components and In-Process Materials |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |