FDA Inspection
Guilin China Resources Tianhe Pharmaceutical Co., Ltd.Guilin China Resources Tianhe Pharmaceutical Co., Ltd. – FDA Inspection, Jan 11, 2019
Record Details
This FDA Inspection record concerns Guilin China Resources Tianhe Pharmaceutical Co., Ltd., with an inspection on January 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 11, 2019
- Product Type
- Drugs
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ID · 497581b2-9e0b-4df5-9e17-370621d1acb6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078047
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Guilin China Resources Tianhe Pharmaceutical Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2025 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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