FDA Inspection
Haimen Pharma Co., Ltd.Haimen Pharma Co., Ltd. – FDA Inspection, Jan 12, 2019
Record Details
This FDA Inspection record concerns Haimen Pharma Co., Ltd., with an inspection on January 12, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 4a747ab0-b511-47c7-b5d1-105fe76954b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078088
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.28(b)Habits of good sanitation & health
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Other FDA inspections of Haimen Pharma Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 10, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 8, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Haimen Pharma Co., Ltd.
- FDA Inspection 1254733 - 2023-08-25
- FDA Inspection 1115958 - 2020-01-10
- FDA Inspection 1027385 - 2017-09-08
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