FDA Inspection
Teikoku Seiyaku Company, Ltd.Teikoku Seiyaku Company, Ltd. – FDA Inspection, Mar 14, 2014
Record Details
This FDA Inspection record concerns Teikoku Seiyaku Company, Ltd., with an inspection on March 14, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 14, 2014
- Product Type
- Drugs
View Company Profile
ID · 43eda829-d901-4cf2-9bc1-c3c0b8141c00
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 873427
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.198(b)(3)Reason for Not Conducting Complaint Investigation
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of Teikoku Seiyaku Company, Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 6, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 9, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 26, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Teikoku Seiyaku Company, Ltd.
- FDA Inspection 1258245 - 2025-02-14
- FDA Inspection 1058444 - 2018-07-06
- FDA Inspection 987969 - 2016-09-09
- FDA Inspection 584346 - 2009-03-26
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