FDA Inspection
Sri Krishna Pharmaceuticals LimitedSri Krishna Pharmaceuticals Limited – FDA Inspection, May 19, 2023
Record Details
This FDA Inspection record concerns Sri Krishna Pharmaceuticals Limited, with an inspection on May 19, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c00c65b4-1cec-4f8b-9bdf-35d0fbd1b46a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1206168
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.186(a)Master production and control records, procedure
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.186(a)Master production and control records, procedure
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Other FDA inspections of Sri Krishna Pharmaceuticals Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2025 | OAI | Office of Inspections and Investigations | Drug Quality Assurance |
| December 4, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 23, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sri Krishna Pharmaceuticals Limited
- FDA Inspection 1273929 - 2025-06-27
- FDA Inspection 913677 - 2014-12-04
- FDA Inspection 757337 - 2011-11-23
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