Hospira Healthcare India Pvt. - July 1, 2016
Issue Date
Jul 01, 2016
Region
HQ
Category
Drug
$117.00
Contact Name
Thomas H. Ludke
Contact Title
Vice President Operations and Site Leader
Address 1
Plot No. 83 S/PCOT Industrial Park
Address 2
Kancheepuram District
City
Tamil Nadu
Zip/Postal Code
602117
Country
India
Inspection Range
Jun 27, 2016 - Jul 01, 2016
Pages
8
First Observation
The list of observations noted below document that the Quality Unit has not performed the necessary assessments/reviews to ensure that the objectionable conditions do not negatively affect the aseptic manufacturing processes and Quality Control tests in support of the finished sterile drug products.
Investigator(s): Thomas J. Arista and Daniel J. Roberts