FDA Inspection 1170460 — Dr. Reddy's Laboratories, Inc.
The FDA completed an inspection of Dr. Reddy's Laboratories, Inc. on May 26, 2022 in Princeton, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 26, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Princeton, NJ (United States)
Additional Details
Risk Evaluation and Mitigation Strategies (REMS)
Citations
| ID | CFR | Description |
|---|---|---|
| 21352 | FDCA 505-1(e)(2)(A) | Failure to comply with REMS Medication Guide |
| 21353 | FDCA 505-1(e)(3) | Failure to comply with REMS Communication Plan |