FDA Inspection
K J I Industrial Co., Ltd.K J I Industrial Co., Ltd. – FDA Inspection, Aug 30, 2012
Record Details
This FDA Inspection record concerns K J I Industrial Co., Ltd., with an inspection on August 30, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- K J I Industrial Co., Ltd.
- Inspection Date
- August 30, 2012
- Product Type
- Drugs
View Company Profile
ID · 5fb79a8d-3602-493d-b444-e987d33f9865
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 798910
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
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