FDA Inspection
Monterey Medical Solutions, Inc.Monterey Medical Solutions, Inc. – FDA Inspection, Jul 31, 2018
Record Details
This FDA Inspection record concerns Monterey Medical Solutions, Inc., with an inspection on July 31, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Seema S. Singh (Issuing Officer)
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ID · ad67ba4f-c5ca-4dca-8f0a-82ccf7277f52
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1060614
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
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