STAT Plus: The FDA warns Pfizer over yet another former Hospira manufacturing plant
Amid ongoing concerns over the pharmaceutical supply chain, the Food and Drug Administration has issued numerous warning letters to domestic drug makers in India about manufacturing issues. But even global companies running plants there are not immune from problems.
On March 25, the agency warned Pfizer (PFE) of signification violations at its Hospira facility in Visakhapatnam, Andhra Pradesh, which makes sterile injectable medicines. The issues involved a failure to adequately investigate various manufacturing deficiencies and an inability to ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs made there.
