FDA Inspection
Petra Hygienic Systems Int LtdPetra Hygienic Systems Int Ltd – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Petra Hygienic Systems Int Ltd, with an inspection on December 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2c54d3b9-50af-4419-8ffd-720f6fca31e2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1075197
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
5- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Petra Hygienic Systems Int Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 12, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 9, 2012 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Petra Hygienic Systems Int Ltd
- FDA Inspection 1168565 - 2022-04-22
- FDA Inspection 911653 - 2014-12-12
- FDA Inspection 770125 - 2012-02-09
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