FDA Inspection
TDS Pharm. Co., Ltd.TDS Pharm. Co., Ltd. – FDA Inspection, Sep 15, 2017
Record Details
This FDA Inspection record concerns TDS Pharm. 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 · 0d3538dc-e0b7-4a9a-a255-e9ec3076c211
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025478
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
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Other FDA inspections of TDS Pharm. Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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