UCP Bioscience Inc
Form 483 issued November 18, 2024 · Milpitas, California
- Inspection
- Nov 8 – Nov 18, 2024
- Investigator
- Brittany D. McCracken
- Observations
- 3
- Pages
- 5
- FEI number
- 3004987297
In short: On November 18, 2024, FDA issued a Form 483 with 3 observations to UCP Bioscience Inc in Milpitas, California (FEI 3004987297) after an inspection that ran Nov 8 – Nov 18, 2024. The investigator was Brittany D. McCracken. Most observations concern design controls and management controls.
At a glance
Design controls and management controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.30(j)21 CFR 820
Observation 1: scanned text, readable in the full document.
- 02
No management representative had been appointed to ensure that quality system requirements are met, and to…
- 03
Written MDR procedures have…
This inspection in context
Brittany D. McCracken
2 documents · 2024
Cites 820 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(j)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at UCP Bioscience Inc?
FDA listed 3 observations on this Form 483, mostly about design controls, management controls and cAPA. The opening words of each observation are shown on this page.
Who inspected UCP Bioscience Inc?
Brittany D. McCracken is named on this Form 483, for the inspection of Nov 8 – Nov 18, 2024. Each investigator has a profile showing what they cite most.
When was UCP Bioscience Inc inspected by FDA?
The inspection ran Nov 8 – Nov 18, 2024, and the Form 483 is dated November 18, 2024.
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.