After months of close oversight by the FDA, repeated inspections and tens of millions of dollars spent on consultants, a new warning letter from the FDA for a Hospira plant in India suggests that the company has yet to learn from its mistakes.
The letter, issued Wednesday for the plant in Irungattukottai, detailed a variety of problems with sterility, some of which may be giving Hospira ($HSP) a little bit of déjà vu. The FDA drew similarities between these issues and some of those raised during February and March inspections of Hospira's Rocky Mount plant, the facility that has been at the heart of its domestic manufacturing problems.
In last year's October inspection of the Irungattukottai facility, FDA officials were not convinced that Hospira could ensure its drugs were sterile. In Wednesday's letter, they cited unsanitized surfaces, airflow questions and even the sterility of gloves worn by workers. The agency ordered Hospira to create a "global corrective action plan" for both its foreign and U.S. plants, including how it intends to train employees involved in aseptic processes.
"Hospira takes this matter seriously and intends to respond fully in a timely manner to the warning letter," a Hospira spokesman told FiercePharmaManufacturing. "We are in regular dialogue with the pharmaceutical side of the FDA. The company has made significant improvements to our plants--in the form of people, processes and modernization, although we still have work to do with our remediation efforts."
Manufacturing problems for Hospira date back to 2010, and since then the company has invested more than $375 million in upgrading and servicing its facilities. But things have still not gone the company's way. The reinspection of the Rocky Mount plant, which Hospira hoped would showcase its remediation efforts, yielded a Form 483 with 20 more observations. Hospira has also seen a steady stream of product recalls in 2013, and earlier this month it received a separate warning letter over problems with its infusion pump manufacturing.
Indian manufacturing has also come into the spotlight over the last couple of weeks. Just after Ranbaxy Laboratories settled a $500 million lawsuit with the U.S. Department of Justice for selling improperly manufactured and tested drugs, Maharashtra-based Wockhardt was hit with an import ban. Hospira expanded its Indian presence last year by buying an API plant in Aurangabad and an R&D operation in Chennai, both purchased from Orchid Chemicals & Pharmaceuticals.
- here's the warning letter
- read Hospira's 8-K
- see Reuters' take