Cardinal Health 414, Inc.
Form 483 issued January 25, 2018 · Seattle, Washington
- Inspection
- Jan 18 – Jan 25, 2018
- Investigators
- Anita Narula· Roger F. Zabinski
- Observations
- 4
- Pages
- 6
- FEI number
- 3003706047
In short: On January 25, 2018, FDA issued a Form 483 with 4 observations to Cardinal Health 414, Inc. in Seattle, Washington (FEI 3003706047) after an inspection that ran Jan 18 – Jan 25, 2018. The investigators were Anita Narula and Roger F. Zabinski.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 212.10
Your personnel lack the training to…
- 02
Your firm lacks adequate production and process controls to ensure the consistent production of a PET…
- 03
Your laboratory analytical methods are not suitable for their intended use and…
- 04
When errors occurred or a production batch failed to meet specifications, you did not determine the…
This inspection in context
Anita Narula
13 documents · 2014–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Oregon.
The firmCardinal Health 414, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 212.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cardinal Health 414, Inc.?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Cardinal Health 414, Inc.?
Anita Narula and Roger F. Zabinski are named on this Form 483, for the inspection of Jan 18 – Jan 25, 2018. Each investigator has a profile showing what they cite most.
When was Cardinal Health 414, Inc. inspected by FDA?
The inspection ran Jan 18 – Jan 25, 2018, and the Form 483 is dated January 25, 2018.
How do I get the full Form 483 for Cardinal Health 414, 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.