Sri Krishna Pharmaceuticals
Quick Facts: Sri Krishna Pharmaceuticals
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- India
- Website
- https://www.srikrishnapharma.com/
- Modalities
- Small Molecule API, Oral Solid Dose
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Sri Krishna Pharmaceuticals
Sri Krishna Pharmaceuticals makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API, Oral Solid Dose. 3 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.srikrishnapharma.com/
Signal Score
Sri Krishna Pharmaceuticals FDA Inspection History
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-06-27 |
Sri Krishna Pharmaceuticals Limited
Hyderabad
Company-level
|
Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
| 2025-04-18 |
SRI Krishna Pharmaceuticals Ltd
Hyderabad
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-09-01 |
SRI Krishna Pharmaceuticals Ltd
Hyderabad
Company-level
|
Drug Quality Assurance | No | Official Action Indicated (OAI) |
| 2023-05-19 |
Sri Krishna Pharmaceuticals Limited
Hyderabad
Company-level
|
Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
Sri Krishna Pharmaceuticals FDA 483 Findings 16 observations · 2023-05-19 → 2025-06-27 ?
By subsystem
By severity
- 5 — Critical: 1
- 3 — Moderate: 4
- 2 — Minor: 11
- Repeat observations: 4
Most severe findings
-
Computer control of master formula records
"Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel."
-
Extent of discrepancy, failure investigations
"Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy."
-
Complaint Investigation/Follow-Up Findings
"Complaint records are deficient in that they do not include the findings of the investigation and follow-up."