Pfizer has again suspended production at a long-troubled sterile injectables plant in India that the FDA has twice before cited for manufacturing and testing issues.
The agency recently outlined problems in a highly redacted, 32-page Form 483 following an inspection of the plant in Irungattukottai, India, a facility that was cited with a Form 483 two years ago and with a warning letter in 2013.
The document includes 11 observations that outline problems with product testing and consistency and which noted that workers “manipulated test sample weights to obtain passing results” for both batches of raw materials and finished product, according to the FDA.
It also says the plant was slow about investigating customer product complaints and points to complaints about a dozen batches for which inspections were not concluded five months after they were received. Seven of the 12 batches had already expired as the investigations were pending. The FDA suggests that many of the plant’s problems stem from poorly trained employees who do not understand the nature of the work they were doing.
In an emailed statement on Monday, Pfizer said it was “disappointed with the outcome” of the inspection and had already submitted a comprehensive response to the FDA.
Pfizer said it is “committed to implementing the necessary improvements and to ensuring the quality of our medicines.” It said it had “voluntarily paused production” at the Irungattukottai, India, site until its internal review and remediation process is complete.
Pfizer bought Hospira in 2015 for $15 billion to get its biosimilars program and its large manufacturing network for generic hospital injectables. At the time of the deal, it assured investors and the FDA that it could fix the manufacturing problems that had long plagued Hospira’s manufacturing operations.
That was easier said than done. Pfizer closed or sold several plants that had accounted for many FDA concerns, but in August 2016, the plant in Irungattukottai, India, was slapped with a Form 483 after having received a warning letter three years earlier. European regulators also noted issues and pulled its manufacturing certificate at the time. The EU inspection uncovered a variety of critical issues that regulators said called into question whether the injectable products coming out of the facility were consistently sterile.
The FDA has also found big issues with a former fill-finish plant in McPherson, Kansas, that was hit with a warning letter last year. Because that plant does a lot of work for other drugmakers, its problems have spilled onto some of Pfizer's clients, even delaying approvals of key products.
But the former Hospira unit is set to get new company oversight. In a reorganization announced last week, the New York drugmaker said that beginning next year it will divide the company into three parts rather than its current two. It put its branded drug business in charge of both biosimilars and the injectable hospital drugs, which have been the target of FDA actions. The other two units will be consumer health and a separate generics business.