FDA Inspection
Myomo IncMyomo Inc – FDA Inspection, Jul 31, 2012
Record Details
This FDA Inspection record concerns Myomo Inc, with an inspection on July 31, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Myomo Inc
- Inspection Date
- July 31, 2012
- Product Type
- Devices
View Company Profile
ID · 68cc1030-0535-4e0e-93c9-913438a77859
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 792698
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of Myomo Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2019 | Not classified | New England District Office |
Other documents for Myomo Inc
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