FDA Inspection
Orean Personal Care LtdOrean Personal Care Ltd – FDA Inspection, Sep 8, 2017
Record Details
This FDA Inspection record concerns Orean Personal Care Ltd, with an inspection on September 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e4a6e367-ca3d-48ff-8409-f8fbb3503196
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025064
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)(3)Valid stability test methods
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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 | |
| March 15, 2024 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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