FDA Inspection
Pietrobon e Cia Ltda.Pietrobon e Cia Ltda. – FDA Inspection, May 10, 2018
Record Details
This FDA Inspection record concerns Pietrobon e Cia Ltda., with an inspection on May 10, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1e37a540-5ce1-4b06-8e09-afe794ee0222
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1051717
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Pietrobon e Cia Ltda.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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