FDA Inspection
DRGEM CORPORATIONDRGEM CORPORATION – FDA Inspection, Feb 24, 2017
Record Details
This FDA Inspection record concerns DRGEM CORPORATION, with an inspection on February 24, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · c5ebfe16-0a76-4668-9059-de9a9f718893
Inspection Facts
- Inspection number
- 1009736
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1002.13Failure to submit
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40Lack of procedures, or not maintained
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Other FDA inspections of DRGEM CORPORATION
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DRGEM CORPORATION
- FDA Inspection 828858 - 2013-04-24
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