FDA Inspection
8046255 Canada Inc.8046255 Canada Inc. – FDA Inspection, Sep 24, 2019
Record Details
This FDA Inspection record concerns 8046255 Canada Inc., with an inspection on September 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e9bd738f-dd17-4f73-ab14-5a1cd3776a0b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1102798
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
9- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.80(a)Procedures To Be in Writing
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