Hospira Inc.
Form 483 issued March 9, 2012 · Clayt o n, North Carolina
- Inspection
- Mar 8 – Mar 9, 2012
- Investigator
- Viviana Matta
- Observations
- 1
- Pages
- 1
- FEI number
- 1048698
In short: On March 9, 2012, FDA issued a Form 483 with 1 observation to Hospira Inc. in Clayt o n, North Carolina (FEI 1048698) after an inspection that ran Mar 8 – Mar 9, 2012. The investigator was Viviana Matta. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Viviana Matta
17 documents · 2012–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmHospira 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Hospira Inc.?
Viviana Matta is named on this Form 483, for the inspection of Mar 8 – Mar 9, 2012. Each investigator has a profile showing what they cite most.
When was Hospira Inc. inspected by FDA?
The inspection ran Mar 8 – Mar 9, 2012, and the Form 483 is dated March 9, 2012.
How do I get the full Form 483 for Hospira 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.