FDA Inspection
Odan Laboratories LtdOdan Laboratories Ltd – FDA Inspection, Feb 20, 2020
Record Details
This FDA Inspection record concerns Odan Laboratories Ltd, with an inspection on February 20, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Odan Laboratories Ltd
- Inspection Date
- February 20, 2020
- Product Type
- Drugs
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ID · 35d5d79c-9e74-44d7-8eaf-b6dd8291cc3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1118442
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Odan Laboratories Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Odan Laboratories Ltd
- FDA Inspection 1035031 - 2017-12-15
- FDA Inspection 967736 - 2016-03-18
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