FDA Inspection
Amsino Healthcare (USA) IncAmsino Healthcare (USA) Inc – FDA Inspection, Aug 30, 2013
Record Details
This FDA Inspection record concerns Amsino Healthcare (USA) Inc, with an inspection on August 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Amsino Healthcare (USA) Inc
- Inspection Date
- August 30, 2013
- Product Type
- Devices
View Company Profile
ID · a1421f25-90ba-484c-964a-4ee851a043a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848405
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.
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Other FDA inspections of Amsino Healthcare (USA) Inc
9| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2025 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 13, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 19, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 10, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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