Hospira, Inc.
Form 483 issued March 1, 2013 · Rocky Mount, North Carolina
- Inspection
- Feb 14 – Feb 23, 2013
- Investigators
- Jason F. Chancey· Penny H. McCarver· Tammara A. Stephens
- Observations
- 20
- Pages
- 22
- FEI number
- 1021343
In short: On March 1, 2013, FDA issued a Form 483 with 20 observations to Hospira, Inc. in Rocky Mount, North Carolina (FEI 1021343) after an inspection that ran Feb 14 – Feb 23, 2013. The investigators were Jason F. Chancey, Penny H. McCarver, Tammara A. Stephens, Thomas J. Arista and Viviana Matta. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 12 of 20 observations.
Most cited: 21 CFR 211.113(b) (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not…
- 03
The responsibilities and procedures applicable to the quaJjty control unit are not in writing and fully…
- 04
Drug product production and control records, are not approved by the quality control unit to determine…
This inspection in context
Jason F. Chancey
2 documents · 2011–2013
Cites 211.192 (production record review) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira, Inc.?
FDA listed 20 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Jason F. Chancey, Penny H. McCarver, Tammara A. Stephens, Thomas J. Arista and Viviana Matta are named on this Form 483, for the inspection of Feb 14 – Feb 23, 2013. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Feb 14 – Feb 23, 2013, and the Form 483 is dated March 1, 2013.
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.