FDA Inspection
TAKA USA, INC.TAKA USA, INC. – FDA Inspection, Feb 7, 2023
Record Details
This FDA Inspection record concerns TAKA USA, INC., with an inspection on February 7, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0fa5e3b6-a221-4e51-900f-5ed1f1afce0d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1196944
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
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Other FDA inspections of TAKA USA, INC.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2026 | VAI | Dallas District Office | Food Composition, Standards, Labeling and Econ |
| September 27, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 6, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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