Cardinal Health, Inc.
Form 483 issued March 18, 2021 · Las Vegas, Nevada
- Inspection
- Mar 16 – Mar 18, 2021
- Investigator
- Scott N. Lim
- Observations
- 1
- Pages
- 3
- FEI number
- 3004771217
In short: On March 18, 2021, FDA issued a Form 483 with 1 observation to Cardinal Health, Inc. in Las Vegas, Nevada (FEI 3004771217) after an inspection that ran Mar 16 – Mar 18, 2021. The investigator was Scott N. Lim. The most-cited regulation is 21 CFR 212.50 (what production and process controls must I have?).
What FDA observed
Preview: the opening words of each observation- 01
Your firm lacks adequate production and process controls to ensure the consistent production of a PET…
This inspection in context
Scott N. Lim
14 documents · 2019–2026
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in California.
The firmCardinal Health, 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 212.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cardinal Health, Inc.?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 212.50 (what production and process controls must I have?). The opening words of each observation are shown on this page.
Who inspected Cardinal Health, Inc.?
Scott N. Lim is named on this Form 483, for the inspection of Mar 16 – Mar 18, 2021. Each investigator has a profile showing what they cite most.
When was Cardinal Health, Inc. inspected by FDA?
The inspection ran Mar 16 – Mar 18, 2021, and the Form 483 is dated March 18, 2021.
How do I get the full Form 483 for Cardinal Health, 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.