FDA Inspection
SGM D.O.O.SGM D.O.O. – FDA Inspection, Aug 25, 2016
Record Details
This FDA Inspection record concerns SGM D.O.O., with an inspection on August 25, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SGM D.O.O.
- Inspection Date
- August 25, 2016
- Product Type
- Devices
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ID · 873e8fa7-e587-4a97-80e2-fbcfb929316a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983863
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 803.17Lack of Written MDR Procedures
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