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FDA Inspection
•Junopacific Inc.•January 24, 2025

Junopacific Inc. – FDA Inspection, Jan 24, 2025

Record Details

This FDA Inspection record concerns Junopacific Inc., with an inspection on January 24, 2025, issued by the Minneapolis District Office, covering medical devices & rad health.

Company
Junopacific Inc.
Inspection Date
January 24, 2025
Product Type
Medical Devices & Rad Health
Office
Minneapolis District Office
People
  • Christina L. Bigham (FDA Associated Person)
  • Shawn Choi (Investigator)
View Company Profile

ID · fbb83f27-0250-4869-b22a-9df07b5486ea

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1261810
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

2
  1. 21 CFR 820.75(a)Lack of or inadequate process validation
  2. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Junopacific Inc.

2
DateClassificationOfficeProject area
November 15, 2022VAICenter for Devices and Radiological HealthCompliance: Devices
July 20, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Junopacific Inc.
  • FDA Inspection 1190592 - 2022-11-15
  • FDA Inspection 987417 - 2016-07-20

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