FDA Intel

Hospira S.p.A.

Form 483 issued May 13, 2014 · Liscate, Italy

Observations
10
Pages
7
FEI number
3004640070

In short: On May 13, 2014, FDA issued a Form 483 with 10 observations to Hospira S.p.A. in Liscate, Italy (FEI 3004640070). Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and laboratory controls account for 8 of 10 observations.

Facilities & equipment4
Laboratory controls4
Production1
Quality system1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…

  2. 02
    21 CFR 211.68(b)

    Appropriate controls are not exercised over computers or related systems to assure that changes in master…

  3. 03
    21 CFR 211.42

    Observation 3: scanned text, readable in the full document.

  4. 04
    21 CFR 211.42(c)(10)(v)

    Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…

6 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The firm

Hospira S.p.A. history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Hospira S.p.A.?

FDA listed 10 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

When was Hospira S.p.A. inspected by FDA?

This Form 483 is dated May 13, 2014.

How do I get the full Form 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.

$99Get it free