FDA Inspection
Aquilo Sports LlcAquilo Sports Llc – FDA Inspection, Jun 26, 2024
Record Details
This FDA Inspection record concerns Aquilo Sports Llc, with an inspection on June 26, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5cc238a1-5a8c-429c-8c56-fb9907a0d2eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1242297
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 801.20(a)Label to bear a unique device identifier
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