FDA Inspection
Omega Laboratories IncOmega Laboratories Inc – FDA Inspection, Apr 26, 2012
Record Details
This FDA Inspection record concerns Omega Laboratories Inc, with an inspection on April 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Omega Laboratories Inc
- Inspection Date
- April 26, 2012
- Product Type
- Devices
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ID · f03e261d-658e-4ba2-9a05-75bf6bf1cf7f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 786093
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Omega Laboratories Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 8, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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