FDA Inspection
Bhargava Phytolab Private LimitedBhargava Phytolab Private Limited – FDA Inspection, Jul 26, 2024
Record Details
This FDA Inspection record concerns Bhargava Phytolab Private Limited, with an inspection on July 26, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d5572f6c-871d-4aac-88b6-2ca500de535b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1244993
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
9- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 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
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