Pfizer Healthcare India Private Limited – FDA 483

An FDA inspection of Hospira Healthcare India Pvt. Ltd. in Visakhapatnam, India, a sterile drug manufacturer, revealed severe deficiencies in microbiological contamination prevention, environmental monitoring, and data integrity. The report highlighted repeated findings of Gram negative and Gram positive organisms, inadequate investigations, and a lack of control over critical manufacturing processes and data. Many of these issues were repeat observations from a previous inspection, indicating persistent quality system failures.