FDA Inspection
Phebra Pty LtdPhebra Pty Ltd – FDA Inspection, Oct 27, 2017
Record Details
This FDA Inspection record concerns Phebra Pty Ltd, with an inspection on October 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0739bcaa-8ad6-409b-b909-d6b748f7deee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029998
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.46(c)Air filtration system lacking in production area
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Phebra Pty Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Phebra Pty Ltd
- FDA Inspection 1111930 - 2019-10-22
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