Compliance Management / Large Molecule

FDA Approves Hospira's India Plant for Limited Production

Jun 24, 2015

On June 23, 2015, Hospira Healthcare India Private Limited, a subsidiary of Hospira Inc., was notified by the U.S. FDA that the inspection of the Visakhapatnam, India, facility was deemed acceptable for the manufacture of finished dosage drugs. Hospira may now receive U.S. product approvals from this facility in the future. The FDA conducted a pre-approval inspection of the Vizag facility in February, which resulted in the issuance of a Form 483 containing 14 observations. Hospira responded to the Form 483 on March 18, 2015, and submitted additional support documentation on May 29, 2015. The inspection was found to be acceptable following the FDA’s review of the company’s responses and support documentation.

Read the SEC filing