Hospira, Inc.
Form 483 issued August 4, 2011 · Rocky Mount, North Carolina
- Inspection
- Jul 25 – Aug 4, 2011
- Investigator
- Daphne Santiago
- Observations
- 3
- Pages
- 6
- FEI number
- 1021343
In short: On August 4, 2011, FDA issued a Form 483 with 3 observations to Hospira, Inc. in Rocky Mount, North Carolina (FEI 1021343) after an inspection that ran Jul 25 – Aug 4, 2011. The investigator was Daphne Santiago. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Daphne Santiago
1 document · 2011
Cites 211.160(b) (general requirements) more than any other section. Most of their documents are for sites in North Carolina.
The firmHospira, Inc. history
All 9 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 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Daphne Santiago is named on this Form 483, for the inspection of Jul 25 – Aug 4, 2011. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Jul 25 – Aug 4, 2011, and the Form 483 is dated August 4, 2011.
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.