Hospira Boulder, Inc.
Form 483 issued September 12, 2002 · McPherson, Kansas
- Observations
- 1
- Pages
- 1
- FEI number
- 1925262
In short: On September 12, 2002, FDA issued a Form 483 with 1 observation to Hospira Boulder, Inc. in McPherson, Kansas (FEI 1925262). Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Questions about this 483
What did FDA find at Hospira Boulder, Inc.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Hospira Boulder, Inc. inspected by FDA?
This Form 483 is dated September 12, 2002.
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.