FDA Inspection
Koroad America, Inc.Koroad America, Inc. – FDA Inspection, May 1, 2019
Record Details
This FDA Inspection record concerns Koroad America, Inc., with an inspection on May 1, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Creighton T. Tuzon (Issuing Officer)
- Eric C. Fox (Investigator)
- Haejung An (Issuing Officer)
- Kevin N. Tran (Investigator)
View Company Profile
ID · b698cd4a-c4b5-4cab-b45f-401dec60557d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1088104
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.20(e)Quality System Procedures
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