FDA Inspection
CEA Medical Manufacturing, Inc. dba Nissha Medical TechnologiesCEA Medical Manufacturing, Inc. dba Nissha Medical Technologies – FDA Inspection, Aug 22, 2013
Record Details
This FDA Inspection record concerns CEA Medical Manufacturing, Inc. dba Nissha Medical Technologies, with an inspection on August 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 22, 2013
- Product Type
- Devices
View Company Profile
ID · f1487018-87b4-4b22-84f8-764a22d2684a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 847231
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| February 5, 2015 | 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 914019 - 2015-02-05
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