FDA Inspection
Brassica Pharma Private LtdBrassica Pharma Private Ltd – FDA Inspection, Jan 19, 2024
Record Details
This FDA Inspection record concerns Brassica Pharma Private Ltd, with an inspection on January 19, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fbc9ac94-0cd1-4cec-a4b9-e8dbb2d2ce2e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1228294
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.100(b)SOPs not followed / documented
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