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.
The problems, which were spotted during an FDA inspection late last summer, were supposed to have been addressed by a so-called corrective and prevention action plan. Instead, the agency took the company to task for failing to implement this plan and pointed to a lack of information about the progress made in a response that Pfizer sent to the FDA last fall.