FDA Inspection
eCordum, Inc.eCordum, Inc. – FDA Inspection, Jul 12, 2023
Record Details
This FDA Inspection record concerns eCordum, Inc., with an inspection on July 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ae0b9e91-52ef-4131-a7f7-d74013a86c53
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210291
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
17- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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