FDA Inspection
Tismor Health and Wellness Pty LimitedTismor Health and Wellness Pty Limited – FDA Inspection, May 24, 2019
Record Details
This FDA Inspection record concerns Tismor Health and Wellness Pty Limited, with an inspection on May 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0ba70960-c846-4b25-843c-bb63a431528b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1090551
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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