FDA Inspection
Amsino Healthcare (USA) IncAmsino Healthcare (USA) Inc – FDA Inspection, Sep 20, 2021
Record Details
This FDA Inspection record concerns Amsino Healthcare (USA) Inc, with an inspection on September 20, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Amsino Healthcare (USA) Inc
- Inspection Date
- September 20, 2021
- Product Type
- Devices
View Company Profile
ID · 906ffd8d-f08e-43e2-aac2-b0a65552912c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1152295
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| July 10, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 12, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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