Cardinal Health 414, LLC
Form 483 issued June 17, 2015 · Fort Lauderdale, Florida
- Inspection
- Jun 9 – Jun 17, 2015
- Investigators
- Ileana Barreto-Pettit· Joanne E. King
- Observations
- 5
- Pages
- 4
- FEI number
- 3003099089
In short: On June 17, 2015, FDA issued a Form 483 with 5 observations to Cardinal Health 414, LLC in Fort Lauderdale, Florida (FEI 3003099089) after an inspection that ran Jun 9 – Jun 17, 2015. The investigators were Ileana Barreto-Pettit and Joanne E. King. 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 observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 212.92
When errors occurred or a production batch failed to meet specifications, you did not determine the…
- 0221 CFR 212.90
Laboratory records did not contain a complete record of all data obtained in the…
- 03
You did not follow procedures to investigate the cause(s) of the nonconforming batch(s) of…
- 04
Your facilities are not adequate to ensure the prevention of contamination of equipment and product by…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmCardinal Health 414, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 212.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cardinal Health 414, LLC?
FDA listed 5 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?
Ileana Barreto-Pettit and Joanne E. King are named on this Form 483, for the inspection of Jun 9 – Jun 17, 2015. Each investigator has a profile showing what they cite most.
When was Cardinal Health 414, LLC inspected by FDA?
The inspection ran Jun 9 – Jun 17, 2015, and the Form 483 is dated June 17, 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.