(Photo Courtesy: www.driverlayer.com)
On February 25, 2015, Hospira Healthcare India Private Limited (Hospira India), a subsidiary of Hospira, Inc., received a Form 483 from the FDA containing 14 observations relating to an inspection of Hospira India's pharmaceutical manufacturing facility nearing commercial operation in Visakhapatnam, India.
The inspection was conducted over the period from February 16 through February 25, 2015.
The company intends to respond fully and in a timely manner to the observations contained in the Form 483.
There can be no assurance that the FDA will be satisfied with the company's response.
The company must obtain the approval of the FDA in order to commercialize products produced at the Vizag facility.