Company
United StatesZoe Medical Incorporated, Topsfield, MA – FDA Inspections
Inspection records and compliance data for Zoe Medical Incorporated in Topsfield, Massachusetts. 5 FDA inspections on record, 1 Form 483, last inspected May 31, 2024.
Company Profile
This profile covers Zoe Medical Incorporated based in Topsfield, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected April 20, 2010. Last inspected May 31, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - production units1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 31, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1240475 |
| September 20, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1102382 |
| October 12, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 990061 |
| February 7, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 817988 |
| April 20, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 657853 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Zoe Medical Incorporated
FEI Number
3003294644
Address
460 Boston St, Topsfield, Massachusetts 01983, United States
Country
United States
ID: b005984a-65d6-45a1-a312-507b883f836a