Company
United StatesFalck Medical Incorporated, Mystic, CT – FDA Inspections
Inspection records and compliance data for Falck Medical Incorporated in Mystic, Connecticut. 3 FDA inspections on record, 1 Form 483, last inspected December 18, 2025.
Company Profile
This profile covers Falck Medical Incorporated based in Mystic, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected January 29, 2016. Last inspected December 18, 2025.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 18, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1296642 |
| August 21, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1216090 |
| January 29, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 959094 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
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Company Information
Name
Falck Medical Incorporated
FEI Number
3003156974
Address
35 Washington St Ste 2, Mystic, Connecticut 06355, United States
Country
United States
ID: 0b85c57f-7c6b-47be-8657-657d98aa4819