FDA Inspection
CEA Medical Manufacturing, Inc. dba Nissha Medical TechnologiesCEA Medical Manufacturing, Inc. dba Nissha Medical Technologies – FDA Inspection, Feb 5, 2015
Record Details
This FDA Inspection record concerns CEA Medical Manufacturing, Inc. dba Nissha Medical Technologies, with an inspection on February 5, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 5, 2015
- Product Type
- Devices
View Company Profile
ID · 51fc2c08-d693-46a4-8bce-53167358fc09
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 914019
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.70(i)Documentation of software validation
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Other FDA inspections of CEA Medical Manufacturing, Inc. dba Nissha Medical Technologies
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2025 | Not classified | Denver District Office | |
| May 26, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CEA Medical Manufacturing, Inc. dba Nissha Medical Technologies
- FDA Inspection 1296668 - 2025-12-11
- FDA Inspection 974429 - 2016-05-26
- FDA Inspection 847231 - 2013-08-22
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