FDA Inspection
TAKA USA, INC.TAKA USA, INC. – FDA Inspection, Sep 27, 2021
Record Details
This FDA Inspection record concerns TAKA USA, INC., with an inspection on September 27, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- TAKA USA, INC.
- Inspection Date
- September 27, 2021
- Product Type
- Drugs
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ID · 803fe5f8-f90e-4e97-bac5-1074d15b6523
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1152898
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 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 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures fail to include
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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 |
| February 7, 2023 | 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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