FDA Inspection
Petra Hygienic Systems Int LtdPetra Hygienic Systems Int Ltd – FDA Inspection, Apr 22, 2022
Record Details
This FDA Inspection record concerns Petra Hygienic Systems Int Ltd, with an inspection on April 22, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 22, 2022
- Product Type
- Drugs
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ID · 20274aca-ddbe-44fa-a2fd-3ace1c2f6d4b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1168565
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Petra Hygienic Systems Int Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2018 | 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 1075197 - 2018-12-21
- FDA Inspection 911653 - 2014-12-12
- FDA Inspection 770125 - 2012-02-09
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