FDA Inspection
Ultra Solutions Manufacturing LLC.Ultra Solutions Manufacturing LLC. – FDA Inspection, Aug 29, 2019
Record Details
This FDA Inspection record concerns Ultra Solutions Manufacturing LLC., with an inspection on August 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 8ee0b8e2-73a2-418d-aea6-16615f870c87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101097
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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.