UCP Bioscience Inc
Form 483 issued March 17, 2017 · San Jose, California
- Inspection
- Feb 13 – Mar 17, 2017
- Investigators
- Mary R. Hole· Sandra S. Saniga
- Observations
- 4
- Pages
- 5
- FEI number
- 3004987297
In short: On March 17, 2017, FDA issued a Form 483 with 4 observations to UCP Bioscience Inc in San Jose, California (FEI 3004987297) after an inspection that ran Feb 13 – Mar 17, 2017. The investigators were Mary R. Hole and Sandra S. Saniga. Most observations concern design controls and clinical (BIMO); the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and clinical (bimo) account for 3 of 4 observations.
Most cited: 21 CFR 820.30 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design validation have…
- 02
The results of design validation, including identification of the design, methods, the date, and the individual(s)…
- 03
Failure to ensure that the requirements for obtaining…
- 0421 CFR 50
Observation 4: scanned text, readable in the full document.
This inspection in context
Mary R. Hole
7 documents · 2013–2017
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmUCP Bioscience Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at UCP Bioscience Inc?
FDA listed 4 observations on this Form 483, mostly about design controls and clinical (BIMO). The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected UCP Bioscience Inc?
Mary R. Hole and Sandra S. Saniga are named on this Form 483, for the inspection of Feb 13 – Mar 17, 2017. Each investigator has a profile showing what they cite most.
When was UCP Bioscience Inc inspected by FDA?
The inspection ran Feb 13 – Mar 17, 2017, and the Form 483 is dated March 17, 2017.
How do I get the full Form 483 for UCP Bioscience Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.