FDA Inspection
Catachem, Inc.Catachem, Inc. – FDA Inspection, Dec 14, 2017
Record Details
This FDA Inspection record concerns Catachem, Inc., with an inspection on December 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9d01eeae-fef0-4cfd-a7c1-78a91f802bbf
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1034866
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Catachem, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 6, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Catachem, Inc.
- FDA Inspection 1283812 - 2025-09-24
- FDA Inspection 1207423 - 2023-06-06
- FDA Inspection 799614 - 2012-09-18
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