FDA Inspection
Petra Hygienic Systems Int LtdPetra Hygienic Systems Int Ltd – FDA Inspection, Dec 12, 2014
Record Details
This FDA Inspection record concerns Petra Hygienic Systems Int Ltd, with an inspection on December 12, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 12, 2014
- Product Type
- Drugs
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ID · 72b5d814-8905-4893-942b-7971a81f2e34
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 911653
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.166(a)Lack of written stability program
- 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 21, 2018 | OAI | 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 1075197 - 2018-12-21
- FDA Inspection 770125 - 2012-02-09
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