FDA Inspection
Seno Medical Instrument IncSeno Medical Instrument Inc – FDA Inspection, Jan 12, 2018
Record Details
This FDA Inspection record concerns Seno Medical Instrument Inc, with an inspection on January 12, 2018, issued by the Dallas District Office, covering medical devices & rad health.
- Company
- Seno Medical Instrument Inc
- Inspection Date
- January 12, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 045141f3-6126-4408-a7cf-dc31b7bfa9a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037795
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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