FDA Inspection
Hubei Biocause Heilen Pharmaceutical Co., Ltd.Hubei Biocause Heilen Pharmaceutical Co., Ltd. – FDA Inspection, Aug 16, 2019
Record Details
This FDA Inspection record concerns Hubei Biocause Heilen Pharmaceutical Co., Ltd., with an inspection on August 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 16, 2019
- Product Type
- Drugs
- Person
- Jay T. Wong (Issuing Officer)
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ID · 19a77013-5b38-4d23-b2ab-d29ad7ccdb22
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100057
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Hubei Biocause Heilen Pharmaceutical Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2025 | Not classified | Office of Inspections and Investigations | |
| November 22, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 4, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hubei Biocause Heilen Pharmaceutical Co., Ltd.
- FDA Inspection 1296860 - 2025-11-14
- FDA Inspection 871443 - 2013-11-22
- FDA Inspection 571882 - 2009-03-04
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