FDA Intel

UCP Bioscience Inc

FDA inspection history across 2 sites, 2017 to 2024

2
Form 483s

Every document, by year

  • Form 483

2017: one Form 483; 2024: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2017One Form 483, at San Jose, California.
  2. 2017The longest 483 on file: 4 observations over 5 pages at San Jose, California.
  3. 2024One Form 483, at Milpitas, California.

Cited most

Across all UCP Bioscience observations on file

  • 21 CFR 820.30
    Design controls
    3
  • 21 CFR 50
    1
  • 21 CFR 820
    1
  • 21 CFR 50.27
    Documentation of informed consent
    1
  • 21 CFR 803.17
    What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
    1

The complete UCP Bioscience file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2024-11-18483 Form 483$99
2017-03-17483 Form 483$99

Investigators on these documents

Brittany D. McCracken (1)Mary R. Hole (1)Sandra S. Saniga (1)

FEI number 3004987297 · most recent document Nov 18, 2024

About UCP Bioscience Inc

How many FDA Form 483s has UCP Bioscience Inc received?

FDA Intel has 2 Form 483s on file for UCP Bioscience Inc; the most recent is dated Nov 18, 2024.

When was UCP Bioscience Inc last inspected by FDA?

The most recent FDA inspection document on file for UCP Bioscience Inc is a Form 483 dated Nov 18, 2024, for the site in Milpitas, California.

What did FDA cite at UCP Bioscience Inc?

The regulations cited most in the observations on file for UCP Bioscience Inc are 21 CFR 820.30 (Design controls), 3 times; 21 CFR 50, 1 time; 21 CFR 820, 1 time.

UCP Bioscience Inc FDA Inspection History & 483s · FDA Intel