FDA Inspection
Orean Personal Care LtdOrean Personal Care Ltd – FDA Inspection, Mar 15, 2024
Record Details
This FDA Inspection record concerns Orean Personal Care Ltd, with an inspection on March 15, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bd33682e-1b98-48b4-ba4c-03c5befb6651
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1234457
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Orean Personal Care Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2026 | Not classified | Office of Inspections and Investigations | |
| September 8, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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