Hospira Inc.
Form 483 issued July 26, 2012 · Clayt o n, North Carolina
- Inspection
- Jul 16 – Jul 26, 2012
- Investigator
- Viviana Matta
- Observations
- 6
- Pages
- 3
- FEI number
- 1048698
In short: On July 26, 2012, FDA issued a Form 483 with 6 observations to Hospira Inc. in Clayt o n, North Carolina (FEI 1048698) after an inspection that ran Jul 16 – Jul 26, 2012. The investigator was Viviana Matta. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The written stability program for drug products does not include…
- 02
Control procedmes are not established which monitor the output and validate the performance ofthose manufacturing processes…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
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 211.166(a)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. 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 Jul 16 – Jul 26, 2012. Each investigator has a profile showing what they cite most.
When was Hospira Inc. inspected by FDA?
The inspection ran Jul 16 – Jul 26, 2012, and the Form 483 is dated July 26, 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.