FDA Inspection
DRGEM Corporation (Gumi Factory)DRGEM Corporation (Gumi Factory) – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns DRGEM Corporation (Gumi Factory), with an inspection on March 3, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- March 3, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · a73d57d0-d7f5-4497-91d0-25c09022ca0f
Inspection Facts
- Inspection number
- 1008517
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 1002.30(a)(2)Basis for selecting methods, devices, procedures
- 21 CFR 1020.30(n)Compliance measurement
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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