FDA Inspection
Inno Health Technology, Inc.Inno Health Technology, Inc. – FDA Inspection, Sep 7, 2023
Record Details
This FDA Inspection record concerns Inno Health Technology, Inc., with an inspection on September 7, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ebd75d23-e7e9-4ce5-8246-8014d9901a30
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1218180
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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