FDA Inspection
Anutra Medical IncAnutra Medical Inc – FDA Inspection, Aug 15, 2018
Record Details
This FDA Inspection record concerns Anutra Medical Inc, with an inspection on August 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 8aa91f6c-f9c5-45af-9650-c2e7174e376d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062209
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.