FDA Inspection
Omega Laboratories Ltd.Omega Laboratories Ltd. – FDA Inspection, Jun 18, 2019
Record Details
This FDA Inspection record concerns Omega Laboratories Ltd., with an inspection on June 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Yumi J. Hiramine (Issuing Officer)
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ID · f4109947-0dec-442a-bc97-17902b05c7d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094223
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.122(a)Written procedures not followed
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Omega Laboratories Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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