Cardinal Health 414 LLC
Form 483 issued October 16, 2015 · Phoenix, Arizona
- Inspection
- Oct 13 – Oct 16, 2015
- Investigators
- Laurimer Kuilan-Torres· Liming Zhang· Roger F. Zabinski
- Observations
- 4
- Pages
- 3
- FEI number
- 3008619510
In short: On October 16, 2015, FDA issued a Form 483 with 4 observations to Cardinal Health 414 LLC in Phoenix, Arizona (FEI 3008619510) after an inspection that ran Oct 13 – Oct 16, 2015. The investigators were Laurimer Kuilan-Torres, Liming Zhang and Roger F. Zabinski. The most-cited regulation is 21 CFR 212.20 (what activities must I perform to ensure drug quality?).
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…
- 02
Yon did not follow…
- 0321 CFR 212.70(c)
You did not conduct an appropriate laboratory determination on a PET drug produced in sub-batches before…
- 04
You did not approve or reject components in a manner that ensures compliance with procedures and…
This inspection in context
Laurimer Kuilan-Torres
16 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmCardinal Health 414 LLC history
The site's inspection history, in date order.
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 414 LLC?
FDA listed 4 observations on this Form 483. The most-cited regulation is 21 CFR 212.20 (what activities must I perform to ensure drug quality?). The opening words of each observation are shown on this page.
Who inspected Cardinal Health 414 LLC?
Laurimer Kuilan-Torres, Liming Zhang and Roger F. Zabinski are named on this Form 483, for the inspection of Oct 13 – Oct 16, 2015. Each investigator has a profile showing what they cite most.
When was Cardinal Health 414 LLC inspected by FDA?
The inspection ran Oct 13 – Oct 16, 2015, and the Form 483 is dated October 16, 2015.
How do I get the full Form 483 for Cardinal Health 414 LLC?
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.