FDA Warns Pfizer Manufacturing Site in India

Following an inspection last August and September, the US Food and Drug Administration (FDA) sent a warning letter to Pfizer’s injectable product manufacturing site in Visakhapatnam, India.

The letter, dated 25 March and released Tuesday, explains how the site did not adequately investigate root causes and implement corrective and preventive action (CAPA) to address deficiencies with its sterility testing.