Company
United StatesZ-Medica, LLC, Wallingford, CT – FDA Inspections
Inspection records and compliance data for Z-Medica, LLC in Wallingford, Connecticut. 6 FDA inspections on record (1 OAI), last inspected March 10, 2023.
Company Profile
This profile covers Z-Medica, LLC based in Wallingford, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected November 3, 2009. Last inspected March 10, 2023.
Most cited issue areas
- Documentation2 inspections
- Lack/Inad procedure-Monitoring/Control of Validated Proces2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 10, 2023 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1201291 |
| May 10, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1053178 |
| April 14, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 925184 |
| April 11, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 777974 |
| February 2, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 643589 |
| November 3, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 626207 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Z-Medica, LLC
FEI Number
3004138549
Address
4 Fairfield Blvd Ste 100, Wallingford, Connecticut 06492, United States
Country
United States
ID: 6ab2ccef-825d-4333-a786-c124813894c3