FDA Inspection 1299974 — Dabur India Limited
The FDA completed an inspection of Dabur India Limited on January 16, 2026 in Dadra And Nagar Haveli. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 16, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dadra And Nagar Haveli (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |