FDA Inspection
Jianerkang Medical Co., LtdJianerkang Medical Co., Ltd – FDA Inspection, Mar 9, 2018
Record Details
This FDA Inspection record concerns Jianerkang Medical Co., Ltd, with an inspection on March 9, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · ce2547d2-fc32-4382-b355-acd2f50640be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046965
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.52Washing and toilet facilities are deficient
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Other FDA inspections of Jianerkang Medical Co., Ltd
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 22, 2024 | Not classified | Office of Inspections and Investigations | |
| November 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 26, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 14, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Jianerkang Medical Co., Ltd
- FDA Inspection 1273963 - 2025-05-22
- FDA Inspection 1257611 - 2024-11-22
- FDA Inspection 1109765 - 2019-11-01
- FDA Inspection 995775 - 2016-08-26
- FDA Inspection 986623 - 2016-04-14
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