FDA Inspection
Amsino Healthcare (USA) IncAmsino Healthcare (USA) Inc – FDA Inspection, Jul 10, 2017
Record Details
This FDA Inspection record concerns Amsino Healthcare (USA) Inc, with an inspection on July 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 47df83e7-f6bc-4944-a161-5b60bf2f68b6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1017381
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.46(c)Air filtration system lacking in production area
Showing 10 of 12 citations.
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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 |
| November 12, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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