Hospira, Inc.
FDA inspection history in Rocky Mount, North Carolina, 2010 to 2023
- 8
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2010: one Form 483; 2011: two Form 483s; 2013: one Form 483; 2014: one warning letter; 2015: one Form 483; 2018: one Form 483; 2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010–15Five Form 483s and one warning letter, at Rocky Mount, North Carolina.
- 2013The longest 483 on file: 20 observations over 22 pages at Rocky Mount, North Carolina.
- 2018–19Two Form 483s, at Rocky Mount, North Carolina.
- 2023One Form 483, at Rocky Mount, North Carolina.
Cited most
Across all Hospira observations on file
- 21 CFR 211.192Production record review8
- 21 CFR 211.160General requirements7
- 21 CFR 211.42(a)Design and construction features5
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products4
- 21 CFR 211.100(a)Written procedures; deviations3
The complete Hospira file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Rocky Mount, North Carolina
Eight Form 483s and one warning letter · 2010 to 2023 · 57 observations
Latest: Form 483, Nov 14, 2023 →
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-14 | 483 Form 483 | Rocky Mount, North Carolina | 1 | $99 |
| 2019-11-21 | 483 Form 483 | Rocky Mount, North Carolina | 3 | $99 |
| 2018-02-02 | 483 Form 483 | Rocky Mount, North Carolina | 4 | $99 |
| 2015-09-24 | 483 Form 483 | Rocky Mount, North Carolina | 2 | $99 |
| 2014-03-07 | Warning letter Warning letter | Rocky Mount, North Carolina | — | $99 |
| 2013-03-01 | 483 Form 483 | Rocky Mount, North Carolina | 20 | $99 |
| 2011-08-04 | 483 Form 483 | Rocky Mount, North Carolina | 3 | $99 |
| 2011-06-17 | 483 Form 483 | Rocky Mount, North Carolina | 18 | $99 |
| 2010-01-19 | 483 Form 483 | Rocky Mount, North Carolina | 6 | $99 |
Investigators on these documents
Claudette D. Brooks (3)Bonita S. Chester (2)Adam R. Cooke (2)Jason F. Chancey (2)Penny H. McCarver (2)Gideon N. Esuzor (1)Thomas R. Berry (1)Lesley K. Satterwhite (1)Viviana Matta (1)Saundrea A. Munroe (1)Sayeeda Hdabe (1)Sonya M. Edmonds (1)
FEI number 1021343 · most recent document Nov 14, 2023
About Hospira, Inc.
How many FDA Form 483s has Hospira, Inc. received?
FDA Intel has 8 Form 483s on file for Hospira, Inc.; the most recent is dated Nov 14, 2023.
When was Hospira, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Hospira, Inc. is a Form 483 dated Nov 14, 2023, for the site in Rocky Mount, North Carolina.
What did FDA cite at Hospira, Inc.?
The regulations cited most in the observations on file for Hospira, Inc. are 21 CFR 211.192 (Production record review), 8 times; 21 CFR 211.160 (General requirements), 7 times; 21 CFR 211.42(a) (Design and construction features), 5 times.
Has Hospira, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hospira, Inc.; the most recent is dated Mar 7, 2014.