Cardinal Health 418, Inc.
Form 483 issued February 21, 2020 · Aurora, Colorado
- Inspection
- Feb 19 – Feb 21, 2020
- Investigator
- Zachary A. Bogorad
- Observations
- 2
- Pages
- 4
- FEI number
- 1717928
In short: On February 21, 2020, FDA issued a Form 483 with 2 observations to Cardinal Health 418, Inc. in Aurora, Colorado (FEI 1717928) after an inspection that ran Feb 19 – Feb 21, 2020. The investigator was Zachary A. Bogorad. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67(a) (1×) · 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Zachary A. Bogorad
12 documents · 2011–2020
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
The firmCardinal Health 418, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cardinal Health 418, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Cardinal Health 418, Inc.?
Zachary A. Bogorad is named on this Form 483, for the inspection of Feb 19 – Feb 21, 2020. Each investigator has a profile showing what they cite most.
When was Cardinal Health 418, Inc. inspected by FDA?
The inspection ran Feb 19 – Feb 21, 2020, and the Form 483 is dated February 21, 2020.
How do I get the full Form 483 for Cardinal Health 418, 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.