FDA Inspection
OMT, LLCOMT, LLC – FDA Inspection, Oct 27, 2009
Record Details
This FDA Inspection record concerns OMT, LLC, with an inspection on October 27, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OMT, LLC
- Inspection Date
- October 27, 2009
- Product Type
- Devices
View Company Profile
ID · e82ddd85-9707-4e54-b094-38bfc718024c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 625447
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.100(b)Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OMT, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2025 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
| September 2, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 15, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 9, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for OMT, LLC
- FDA Inspection 1262755 - 2025-03-05
- FDA Inspection 1179087 - 2022-09-02
- FDA Inspection 992511 - 2016-11-15
- FDA Inspection 815073 - 2013-01-09
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