Hospira S.p.A.
FDA inspection history across 2 sites, 2014 to 2022
- 2
- Form 483s
- 2
- Warning letters
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
- Warning letter
2014: one Form 483; 2015: two warning letters; 2017: one close-out letter; 2022: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–17Two warning letters, one Form 483 and one close-out letter, at Liscate, Italy and Lake Forest, Illinois.
- 2014The longest 483 on file: 10 observations over 7 pages at Liscate, Italy.
- 2022One amended 483, at Liscate, Italy.
Cited most
Across all Hospira S.p.A. observations on file
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.160(a)General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.170(b)Reserve samples1
The complete Hospira S.p.A. file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Liscate, Italy
One amended 483, one close-out letter, one warning letter and one Form 483 · 2014 to 2022 · 13 observations
Latest: Form 483, Dec 6, 2022 →Lake Forest, Illinois
One warning letter · 2015
Latest: Warning letter, Mar 31, 2015 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-06 | Amended 483 Amended 483 | Liscate, Italy | 3 | $99 |
| 2017-06-13 | Close-out Close-out letter | Liscate, Italy | — | $99 |
| 2015-03-31 | Warning letter Warning letter | Lake Forest, Illinois | — | $99 |
| 2015-03-31 | Warning letter Warning letter | Liscate, Italy | — | $99 |
| 2014-05-13 | 483 Form 483 | Liscate, Italy | 10 | $99 |
Investigators on these documents
FEI number 3004640070 · most recent document Dec 6, 2022
About Hospira S.p.A.
How many FDA Form 483s has Hospira S.p.A. received?
FDA Intel has 2 Form 483s on file for Hospira S.p.A.; the most recent is dated Dec 6, 2022.
When was Hospira S.p.A. last inspected by FDA?
The most recent FDA inspection document on file for Hospira S.p.A. is a Form 483 dated Dec 6, 2022, for the site in Liscate, Italy.
What did FDA cite at Hospira S.p.A.?
The regulations cited most in the observations on file for Hospira S.p.A. are 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.160(a) (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times.
Has Hospira S.p.A. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Hospira S.p.A.; the most recent is dated Mar 31, 2015.