Cardinal Health 414, Inc.

FDA inspection history in Seattle, Washington, 2018 to 2020

2
Form 483s

Every document, by year

  • Form 483

2018: one Form 483; 2020: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2018–20Two Form 483s, at Seattle, Washington.
  2. 2018The longest 483 on file: 4 observations over 6 pages at Seattle, Washington.

Cited most

Across all Cardinal Health 414 observations on file

  • 21 CFR 212.20(d)
    What activities must I perform to ensure drug quality?
    3
  • 21 CFR 212.50
    What production and process controls must I have?
    2
  • 21 CFR 212.10
    What personnel and resources must I have?
    1
  • 21 CFR 212.60(c)
    What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?
    1

The complete Cardinal Health 414 file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2020-02-25483 Form 483$99
2018-01-25483 Form 483$99

Investigators on these documents

Anita Narula (2)Roger F. Zabinski (1)

FEI number 3003706047 · most recent document Feb 25, 2020

About Cardinal Health 414, Inc.

How many FDA Form 483s has Cardinal Health 414, Inc. received?

FDA Intel has 2 Form 483s on file for Cardinal Health 414, Inc.; the most recent is dated Feb 25, 2020.

When was Cardinal Health 414, Inc. last inspected by FDA?

The most recent FDA inspection document on file for Cardinal Health 414, Inc. is a Form 483 dated Feb 25, 2020, for the site in Seattle, Washington.

What did FDA cite at Cardinal Health 414, Inc.?

The regulations cited most in the observations on file for Cardinal Health 414, Inc. are 21 CFR 212.20(d) (What activities must I perform to ensure drug quality?), 3 times; 21 CFR 212.50 (What production and process controls must I have?), 2 times; 21 CFR 212.10 (What personnel and resources must I have?), 1 time.