FDA Inspection
Jianerkang Medical Co., LtdJianerkang Medical Co., Ltd – FDA Inspection, Apr 2, 2014
Record Details
This FDA Inspection record concerns Jianerkang Medical Co., Ltd, with an inspection on April 2, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Jianerkang Medical Co., Ltd
- Inspection Date
- April 2, 2014
- Product Type
- Drugs
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ID · 60d0392f-5b29-4d0b-ad7a-86a19d72e006
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 880522
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 820.70(f)Buildings
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 820.70(a)Production processes
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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 |
| March 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 26, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 1046965 - 2018-03-09
- FDA Inspection 995775 - 2016-08-26
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