FDA Inspection
General Medical CompanyGeneral Medical Company – FDA Inspection, Jul 23, 2019
Record Details
This FDA Inspection record concerns General Medical Company, with an inspection on July 23, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 520c5874-7b19-47c2-8589-74ea3b8e2f05
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097606
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.180Availability
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of General Medical Company
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 29, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for General Medical Company
- FDA Inspection 946020 - 2015-10-30
- FDA Inspection 817421 - 2013-01-29
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