FDA Inspection
AHA TECHNOLOGIES, INC.AHA TECHNOLOGIES, INC. – FDA Inspection, Oct 14, 2025
Record Details
This FDA Inspection record concerns AHA TECHNOLOGIES, INC., with an inspection on October 14, 2025, issued by the Detroit District Office, covering medical devices & rad health.
- Company
- AHA TECHNOLOGIES, INC.
- Inspection Date
- October 14, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 70eab103-9e0a-404e-9ae3-21d6caeacfe3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1287024
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
10- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.100(a)Lack of or inadequate procedures
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