FDA Inspection
Vesta Inc.Vesta Inc. – FDA Inspection, May 20, 2014
Record Details
This FDA Inspection record concerns Vesta Inc., with an inspection on May 20, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vesta Inc.
- Inspection Date
- May 20, 2014
- Product Type
- Devices
View Company Profile
ID · 97fd79fb-3461-4cf9-a984-9f4e6eaea019
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 880201
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vesta Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 31, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 20, 2017 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| July 20, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vesta Inc.
- FDA Inspection 1264302 - 2025-03-13
- FDA Inspection 1118871 - 2020-01-31
- FDA Inspection 1030227 - 2017-10-20
- FDA Inspection 1019861 - 2017-07-20
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