Company
United StatesZyno Medical LLC, Natick, MA – FDA Inspections
Inspection records and compliance data for Zyno Medical LLC in Natick, Massachusetts. 7 FDA inspections on record (3 OAI), 3 Form 483s, 1 warning letter, last inspected September 18, 2025.
Company Profile
This profile covers Zyno Medical LLC based in Natick, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 3
- VAI
- 3
- NAI
- 1
- Form 483s
- 3
- Warning letters
- 1
First inspected October 24, 2008. Last inspected September 18, 2025.
Most cited issue areas
- Individual Report of Malfunction5 inspections
- Lack of or inadequate procedures3 inspections
- Lack of or inadequate complaint procedures2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1241357 |
| August 16, 2023 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1215340 |
| February 15, 2022 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1162461 |
| December 15, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1035238 |
| August 11, 2016 | OAI | Medical Devices & Rad Health · Compliance: Devices | 981584 |
| August 22, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 795500 |
| October 24, 2008 | NAI | Medical Devices & Rad Health · Compliance: Devices | 546310 |
FDA documents
Form 483s (4)
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Zyno Medical LLC
FEI Number
3006575795
Address
177 Pine St, Natick, Massachusetts 01760, United States
Country
United States
ID: d35883d0-5ef2-4a3b-8613-178bd16faec4