Inspection Record

Hospira Inc. — FDA 483 Findings

US FDAInspected 2015-07-10Published 2024-01-17 6 findingsLaboratory and QC controlsProcess validationComplaint and recall handlingEquipment and facility

Inspectors Viviana Matta · Ph. DThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory and QC controls

The written stability program for drug products does not include meaningful test methods.

2Laboratory and QC controls

Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

3Process validation

Control procedmes are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

4Complaint and recall handling

An NDA-Field Alert Report was not submitted within three working days of receipt ofinfonnation concerning a failure of one or more distributed batches ofa drug to meet the specifications established for it in the application.

5Process validation

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

6Equipment and facility

Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2026-03-10 · US FDA · 6 findings2015-07-10 · US FDA · 19 findings2015-07-10 · US FDA · 20 findings2015-07-11 · US FDA · 18 findings2021-11-08 · Health Canada · 8 findings2020-01-17 · US FDA · 9 findings
Hospira Inc. findings history — including this company's other documents US FDA documents, 2024 Go to Findings search