Company
United StatesCatachem, Inc., Oxford, CT – FDA Inspections
Inspection records and compliance data for Catachem, Inc. in Oxford, Connecticut. 4 FDA inspections on record, 1 Form 483, last inspected September 24, 2025.
Company Profile
This profile covers Catachem, Inc. based in Oxford, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected September 18, 2012. Last inspected September 24, 2025.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Complaints1 inspection
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 24, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1283812 |
| June 6, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1207423 |
| December 14, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1034866 |
| September 18, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 799614 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Catachem, Inc.
FEI Number
2434178
Address
353 Christian St Ste 2, Oxford, Connecticut 06478, United States
Country
United States
ID: 34df6c53-03f2-4bc1-8afe-c4ac72f29e21