FDA Inspection
Omega Laboratories IncOmega Laboratories Inc – FDA Inspection, Feb 8, 2024
Record Details
This FDA Inspection record concerns Omega Laboratories Inc, with an inspection on February 8, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5fb85168-900d-48e3-ac65-91de8b775b33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228838
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Omega Laboratories Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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