Hospira S.p.A.
Amended 483 issued December 6, 2022 · Liscate, Italy
- Inspection
- Nov 28 – Dec 6, 2022
- Investigator
- William Leonard
- Observations
- 3
- Pages
- 3
- FEI number
- 3004640070
In short: On December 6, 2022, FDA issued a Amended 483 with 3 observations to Hospira S.p.A. in Liscate, Italy (FEI 3004640070) after an inspection that ran Nov 28 – Dec 6, 2022. The investigator was William Leonard. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not include…
- 02
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing…
- 03
The batch production and control records are deficient in that they do not include documentation of…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
William Leonard
17 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmHospira S.p.A. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Hospira S.p.A.?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Hospira S.p.A.?
William Leonard is named on this Amended 483, for the inspection of Nov 28 – Dec 6, 2022. Each investigator has a profile showing what they cite most.
When was Hospira S.p.A. inspected by FDA?
The inspection ran Nov 28 – Dec 6, 2022, and the Amended 483 is dated December 6, 2022.
How do I get the full Amended 483 for Hospira S.p.A.?
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.