FDA Inspection
Zyno Medical LLCZyno Medical LLC – FDA Inspection, Aug 11, 2016
Record Details
This FDA Inspection record concerns Zyno Medical LLC, with an inspection on August 11, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zyno Medical LLC
- Inspection Date
- August 11, 2016
- Product Type
- Devices
View Company Profile
ID · 6d30d53d-02a2-4d97-ad6e-1be693b7f69f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 981584
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zyno Medical LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2025 | VAI | New England District Office | Compliance: Medical Devices |
| August 16, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 15, 2022 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 15, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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