Hospira, Inc.
Form 483 issued November 21, 2019 · Rocky Mount, North Carolina
- Inspection
- Nov 12 – Nov 21, 2019
- Investigators
- Adam R. Cooke· Gideon N. Esuzor· Sonya M. Edmonds
- Observations
- 3
- Pages
- 4
- FEI number
- 1021343
In short: On November 21, 2019, FDA issued a Form 483 with 3 observations to Hospira, Inc. in Rocky Mount, North Carolina (FEI 1021343) after an inspection that ran Nov 12 – Nov 21, 2019. The investigators were Adam R. Cooke, Gideon N. Esuzor and Sonya M. Edmonds. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Written records of investigations into do not always include…
This inspection in context
Adam R. Cooke
11 documents · 2015–2021
Cites 211.42 (design and construction features) 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 most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Adam R. Cooke, Gideon N. Esuzor and Sonya M. Edmonds are named on this Form 483, for the inspection of Nov 12 – Nov 21, 2019. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Nov 12 – Nov 21, 2019, and the Form 483 is dated November 21, 2019.
How do I get the full Form 483 for Hospira, Inc.?
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