FDA Inspection
Hy-Sun Biomedical, Inc.Hy-Sun Biomedical, Inc. – FDA Inspection, Feb 9, 2017
Record Details
This FDA Inspection record concerns Hy-Sun Biomedical, Inc., with an inspection on February 9, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Edward M. James (Issuing Officer)
- Zachary P. Wachlarowicz (Company Rep)
View Company Profile
ID · 9b39b1ec-5331-495b-8fb2-1b9945bf6759
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000700
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.123(a)(1)Quality control operations - master manufacturing record, modifications
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Other FDA inspections of Hy-Sun Biomedical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2016 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Hy-Sun Biomedical, Inc.
- FDA Inspection 973873 - 2016-06-02
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