Golden Sunshine International Inc. – FDA Inspection, Sep 27, 2018

Record Details

This FDA Inspection record concerns Golden Sunshine International Inc., with an inspection on September 27, 2018, issued by the Denver District Office, covering human drugs.

Company: Golden Sunshine International Inc.
Inspection Date: September 27, 2018
Product Type: Human Drugs
Office: Denver District Office
Person: Zachary L. Stamm (FDA Associated Person)

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ID · 9801cfd3-b7fe-44db-aef6-5074a05ef935

Inspection Facts

Inspection number: 1066902
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.166(a)Lack of written stability program
21 CFR 211.196Distribution Record Requirements
21 CFR 211.22(a)Lack of quality control unit

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FDA Inspection

Golden Sunshine International Inc.September 27, 2018