Hospira Boulder, Inc.

Form 483 issued October 24, 2012 · McPherson, Kansas

Inspection
Oct 9 – Oct 24, 2012
Observations
2
Pages
3
FEI number
1925262

In short: On October 24, 2012, FDA issued a Form 483 with 2 observations to Hospira Boulder, Inc. in McPherson, Kansas (FEI 1925262) after an inspection that ran Oct 9 – Oct 24, 2012. The investigator was Teresa B. Breckenridge.

What FDA observed

Preview: the opening words of each observation
  1. 01

    Procedures designed to prevent microbiological contamination of drug products purporting to be…

  2. 02

    Investigations of an unexplained discrepancy did not extend to other drug products that may have been…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

Questions about this 483

What did FDA find at Hospira Boulder, Inc.?

FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.

Who inspected Hospira Boulder, Inc.?

Teresa B. Breckenridge is named on this Form 483, for the inspection of Oct 9 – Oct 24, 2012. Each investigator has a profile showing what they cite most.

When was Hospira Boulder, Inc. inspected by FDA?

The inspection ran Oct 9 – Oct 24, 2012, and the Form 483 is dated October 24, 2012.

How do I get the full Form 483 for Hospira Boulder, 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.

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