FDA Inspection
Pro Med Instruments, Inc.Pro Med Instruments, Inc. – FDA Inspection, Feb 15, 2023
Record Details
This FDA Inspection record concerns Pro Med Instruments, Inc., with an inspection on February 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3c9502b2-e564-4dea-ae9a-9a4f9fd24ec7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198065
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 803.42(e)(1)Whether reporter is an importer
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.200(d)Service reports
- 21 CFR 803.42(e)(1)Whether reporter is an importer
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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