FDA Inspection
Shenzhen Osto Medical Technology Co.,LTDShenzhen Osto Medical Technology Co.,LTD – FDA Inspection, Mar 20, 2025
Record Details
This FDA Inspection record concerns Shenzhen Osto Medical Technology Co.,LTD, with an inspection on March 20, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- March 20, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 34f0525f-4fdd-494e-bfaa-c6ad39fe81f9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1264480
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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