Hospira, Inc.
Form 483 issued November 14, 2023 · Rocky Mount, North Carolina
- Inspection
- Nov 6 – Nov 14, 2023
- Investigator
- Saundrea A. Munroe
- Observations
- 1
- Pages
- 3
- FEI number
- 1021343
In short: On November 14, 2023, FDA issued a Form 483 with 1 observation to Hospira, Inc. in Rocky Mount, North Carolina (FEI 1021343) after an inspection that ran Nov 6 – Nov 14, 2023. The investigator was Saundrea A. Munroe. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
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 211.160
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 laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Saundrea A. Munroe is named on this Form 483, for the inspection of Nov 6 – Nov 14, 2023. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Nov 6 – Nov 14, 2023, and the Form 483 is dated November 14, 2023.
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.