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FDA Inspection
•Hitachi High-Technologies Corp., Omuta Center•February 28, 2019

Hitachi High-Technologies Corp., Omuta Center – FDA Inspection, Feb 28, 2019

Record Details

This FDA Inspection record concerns Hitachi High-Technologies Corp., Omuta Center, with an inspection on February 28, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company
Hitachi High-Technologies Corp., Omuta Center
Inspection Date
February 28, 2019
Product Type
Medical Devices & Rad Health
Office
Office of Inspections and Investigations
Person
  • Stephen C. Smith (FDA Associated Person)
View Company Profile

ID · 48aeef04-ffb2-4ef1-b2c7-91a9b7e79bf6

Inspection Facts

Inspection number
1081543
FDA center
Medical Devices & Rad Health
Project area
Project Evaluation: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
  2. 21 CFR 820.86Acceptance status

Full citation text and observation details available on the Dashboard.

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