FDA Inspection
Catachem, Inc.Catachem, Inc. – FDA Inspection, Sep 18, 2012
Record Details
This FDA Inspection record concerns Catachem, Inc., with an inspection on September 18, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Catachem, Inc.
- Inspection Date
- September 18, 2012
- Product Type
- Devices
View Company Profile
ID · d3f56ad4-0054-42ad-be9f-a0dc880c2462
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 799614
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| December 14, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Catachem, Inc.
- FDA Inspection 1283812 - 2025-09-24
- FDA Inspection 1207423 - 2023-06-06
- FDA Inspection 1034866 - 2017-12-14
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