FDA Inspection
Polaroisin International Co., Ltd.Polaroisin International Co., Ltd. – FDA Inspection, Sep 15, 2017
Record Details
This FDA Inspection record concerns Polaroisin International Co., Ltd., with an inspection on September 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b8c8f8e3-ef04-40cf-af62-623ec142f188
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1028352
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
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