Cardinal Health 414 LLC
Form 483 issued June 18, 2019 · E. Hartford, Connecticut
- Inspection
- Jun 11 – Jun 18, 2019
- Investigator
- Sean R. Marcsisin
- Observations
- 1
- Pages
- 2
- FEI number
- 3006786767
In short: On June 18, 2019, FDA issued a Form 483 with 1 observation to Cardinal Health 414 LLC in E. Hartford, Connecticut (FEI 3006786767) after an inspection that ran Jun 11 – Jun 18, 2019. The investigator was Sean R. Marcsisin. The most-cited regulation is 21 CFR 212.60 (what requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?).
What FDA observed
Preview: the opening words of each observation- 01
Your quality of supplies used in your testing procedures…
This inspection in context
Sean R. Marcsisin
22 documents · 2016–2025
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Massachusetts.
The firmCardinal Health 414 LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 212.60(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cardinal Health 414 LLC?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 212.60 (what requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?). The opening words of each observation are shown on this page.
Who inspected Cardinal Health 414 LLC?
Sean R. Marcsisin is named on this Form 483, for the inspection of Jun 11 – Jun 18, 2019. Each investigator has a profile showing what they cite most.
When was Cardinal Health 414 LLC inspected by FDA?
The inspection ran Jun 11 – Jun 18, 2019, and the Form 483 is dated June 18, 2019.
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.