FDA Inspection 1273929 — Sri Krishna Pharmaceuticals Limited
The FDA completed an inspection of Sri Krishna Pharmaceuticals Limited on June 27, 2025 in Hyderabad. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 27, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hyderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |