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FDA Inspection
•Sunsho Pharmaceutical Co., Ltd.•April 17, 2025

Sunsho Pharmaceutical Co., Ltd. – FDA Inspection, Apr 17, 2025

Record Details

This FDA Inspection record concerns Sunsho Pharmaceutical Co., Ltd., with an inspection on April 17, 2025, issued by the Office of Inspections and Investigations, covering foods & cosmetics.

Company
Sunsho Pharmaceutical Co., Ltd.
Inspection Date
April 17, 2025
Product Type
Foods & Cosmetics
Office
Office of Inspections and Investigations
Person
  • Diana K. Krepel (Company Rep)
View Company Profile

ID · 7bbc3421-19a8-46bf-9100-5c47b28db70b

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1267026
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling, and Economics
Outcome
Form 483 issued, view the record

FDA Citations

7
  1. 21 CFR 111.70(b)Specifications - components
  2. 21 CFR 111.410(b)Label, packaging - discrepancies
  3. 21 CFR 111.70(e)Specifications - finished dietary supplement
  4. 21 CFR 111.205(a)Master manufacturing record - followed
  5. 21 CFR 111.320(b)Examination, testing; scientifically valid
  6. 21 CFR 111.260Batch record - required information
  7. 21 CFR 111.210Master manufacturing record - record requirements

Full citation text and observation details available on the Dashboard.

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