DAEHWA PHARM CO.,LTD. – FDA Inspection, Nov 1, 2019

Record Details

This FDA Inspection record concerns DAEHWA PHARM CO.,LTD., with an inspection on November 1, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: DAEHWA PHARM CO.,LTD.
Inspection Date: November 1, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 80b72bc4-bcfe-42a4-8c8d-b586c625c35d

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1108243
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.68(b)Computer control of master formula records
21 CFR 211.194(a)Complete test data included in records

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FDA Inspection

DAEHWA PHARM CO.,LTD.November 1, 2019