FDA Inspection
Unique Safety Equipment Co., LtdUnique Safety Equipment Co., Ltd – FDA Inspection, May 29, 2025
Record Details
This FDA Inspection record concerns Unique Safety Equipment Co., Ltd, with an inspection on May 29, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- May 29, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 8a83a8b5-ac56-4b9e-ba12-04435cc91b92
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1272456
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Unique Safety Equipment Co., Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Unique Safety Equipment Co., Ltd
- FDA Inspection 1083839 - 2019-02-27
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