FDA Inspection
Hana Microelectronics Public Co LtdHana Microelectronics Public Co Ltd – FDA Inspection, Apr 25, 2019
Record Details
This FDA Inspection record concerns Hana Microelectronics Public Co Ltd, with an inspection on April 25, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- April 25, 2019
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 5f06aa17-f88c-465d-9f27-a9b51028ecce
Inspection Facts
- Inspection number
- 1089636
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.184(f)DHR - UDI not included
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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