Cardinal Health 414, LLC
Form 483 issued August 3, 2018 · New Orleans, Louisiana
- Inspection
- Jul 31 – Aug 3, 2018
- Investigator
- Claire M. Minden
- Observations
- 2
- Pages
- 2
- FEI number
- 3012304786
In short: On August 3, 2018, FDA issued a Form 483 with 2 observations to Cardinal Health 414, LLC in New Orleans, Louisiana (FEI 3012304786) after an inspection that ran Jul 31 – Aug 3, 2018. The investigator was Claire M. Minden. The most-cited regulation is 21 CFR 212.30 (what requirements must my facilities and equipment meet?).
What FDA observed
Preview: the opening words of each observation- 01
You did not implement procedures to ensure that all equipment is cleaned, suitable for its intended…
- 02
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmCardinal Health 414, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 212.30(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cardinal Health 414, LLC?
FDA listed 2 observations on this Form 483. The most-cited regulation is 21 CFR 212.30 (what requirements must my facilities and equipment meet?). The opening words of each observation are shown on this page.
Who inspected Cardinal Health 414, LLC?
Claire M. Minden is named on this Form 483, for the inspection of Jul 31 – Aug 3, 2018. Each investigator has a profile showing what they cite most.
When was Cardinal Health 414, LLC inspected by FDA?
The inspection ran Jul 31 – Aug 3, 2018, and the Form 483 is dated August 3, 2018.
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.