FDA Inspection
ILLES CSOK ES TSAILLES CSOK ES TSA – FDA Inspection, Nov 2, 2017
Record Details
This FDA Inspection record concerns ILLES CSOK ES TSA, with an inspection on November 2, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b3c910f2-2dfe-44b2-b44d-8a7ecf8d42de
Inspection Facts
- Inspection number
- 1030500
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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