FDA Inspection
Chilecom Medical Devices Co. Ltd.Chilecom Medical Devices Co. Ltd. – FDA Inspection, Feb 9, 2018
Record Details
This FDA Inspection record concerns Chilecom Medical Devices Co. Ltd., with an inspection on February 9, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- February 9, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · c6648448-8790-474a-8658-b97f5a8979a5
Inspection Facts
- Inspection number
- 1044744
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation - simulated testing
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.70(f)Buildings
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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