FDA Inspection
PresbiBio, LLCPresbiBio, LLC – FDA Inspection, Mar 18, 2019
Record Details
This FDA Inspection record concerns PresbiBio, LLC, with an inspection on March 18, 2019, issued by the Los Angeles District Office, covering medical devices & rad health.
View Company Profile
ID · 568fc4ba-2c61-4724-9b0b-e5a9b17e395b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082994
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PresbiBio, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for PresbiBio, LLC
- FDA Inspection 970189 - 2016-04-28
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.