Hospira, Inc.
Form 483 issued September 20, 2024 · Austin, Texas
- Inspection
- Sep 9 – Sep 20, 2024
- Investigators
- Miguel A. Martinez· Santos E. Camara
- Observations
- 10
- Pages
- 25
- FEI number
- 1628454
In short: On September 20, 2024, FDA issued a Form 483 with 10 observations to Hospira, Inc. in Austin, Texas (FEI 1628454) after an inspection that ran Sep 9 – Sep 20, 2024. The investigators were Miguel A. Martinez and Santos E. Camara. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 6 of 10 observations.
Most cited: 21 CFR 211.160 (3×) · 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The written stability testing…
- 03
The written stability program for drug products does not include test intervals based on statistical criteria…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Miguel A. Martinez
16 documents · 2014–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmHospira, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira, Inc.?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Hospira, Inc.?
Miguel A. Martinez and Santos E. Camara are named on this Form 483, for the inspection of Sep 9 – Sep 20, 2024. Each investigator has a profile showing what they cite most.
When was Hospira, Inc. inspected by FDA?
The inspection ran Sep 9 – Sep 20, 2024, and the Form 483 is dated September 20, 2024.
How do I get the full Form 483 for Hospira, Inc.?
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.