FDA Inspection
Goodman Company, Ltd.Goodman Company, Ltd. – FDA Inspection, Jan 25, 2024
Record Details
This FDA Inspection record concerns Goodman Company, Ltd., with an inspection on January 25, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ca4798a5-51b5-428f-b04a-1210067df071
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1227867
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Goodman Company, Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2025 | Not classified | Office of Inspections and Investigations | Product Evaluation: Medical Devices |
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