USFDA has issued warning letter to Hospira’s Italian facility

Hospira has received warning letter from USFDA for its Italy based plant on 31st March, 2015. Hospira makes biosimilars and a generic version of injectable drugs as well as pumps used to deliver them, has received warning letters for multiple facilities the past year. Hospira has also recalled its drug from market many times. The FDA inspector has identified four significant violations which are as follows:

  • Failure to establish procedures to prevent contamination for the drug purporting to be sterile

  • Failure to thoroughly investigate instances where a batch did not meet specifications during.

  • Failure to control who is allowed to make changes in master production and control records

  • Failure to ensure that the laboratory records include all data derived from all test necessary

The inspector said Hospira's response for FDA concern lacks corrective actions. USFDA also warned in its letter that it could withhold approval of new applications or supplements made by Hospira until it confirmed that the facility was FDA-compliant.