Hospira, Inc.
Form 483 issued January 19, 2010 · Rocky Mount, North Carolina
- Inspection
- Jan 12 – Jan 19, 2010
- Investigator
- Thomas R. Berry
- Observations
- 6
- Pages
- 3
- FEI number
- 1021343
In short: On January 19, 2010, FDA issued a Form 483 with 6 observations to Hospira, Inc. in Rocky Mount, North Carolina (FEI 1021343) after an inspection that ran Jan 12 – Jan 19, 2010. The investigator was Thomas R. Berry. Most observations concern production & process controls and production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production & process controls and production account for 5 of 6 observations.
Most cited: 21 CFR 820.70(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
In.process specifications are not determined by the application of suitable…
- 03
Production processes were not developed and complete to ensure that a device…
- 04
Process control procedures that describe any process controls necessary to ensure conformance to specifications were not…
This inspection in context
Thomas R. Berry
1 document · 2010
Cites 211.110(a) (sampling and testing of in-process materials and drug products) 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 820.70(a)
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 production & process controls, production and cAPA. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Thomas R. Berry is named on this Form 483, for the inspection of Jan 12 – Jan 19, 2010. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Jan 12 – Jan 19, 2010, and the Form 483 is dated January 19, 2010.
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.