FDA Inspection 1012606 — APL Healthcare Limited
The FDA completed an inspection of APL Healthcare Limited on March 31, 2017 in Mahaboob Nagar (District). 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
- March 31, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mahaboob Nagar (District) (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |