FDA Inspection
J. Morita Mfg. Corp.J. Morita Mfg. Corp. – FDA Inspection, Apr 7, 2017
Record Details
This FDA Inspection record concerns J. Morita Mfg. Corp., with an inspection on April 7, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Shafiq Ahadi (Issuing Officer)
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ID · f721d3c0-5ae3-45ee-a311-394172813b28
Inspection Facts
- Inspection number
- 1011372
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Documentation of software validation
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Other FDA inspections of J. Morita Mfg. Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 3, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for J. Morita Mfg. Corp.
- FDA Inspection 749036 - 2011-08-26
- FDA Inspection 714980 - 2011-03-03
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