When the FDA finds deep flaws at a manufacturing plant, it questions practices at all other facilities in the network. Hospira ($HSP) found this out in 2010 when a second warning letter in 8 months prompted the FDA to ask it to do a global review, and Wockhardt has now been given a similar regulatory to-do list.
The FDA asked Wockhardt to do a global assessment of its manufacturing processes after inspecting its plants in Chikalthana and Waluj, India, in July. Failings at both plants are detailed in an FDA warning letter released this week. The two sites share many of the same problems, notably the running of "trial" sample analyses before acquiring "official" data for release and stability testing. With both facilities having the same, fundamental flaw in their quality testing methods, FDA is skeptical about data from all of Wockhardt's sites.
Other aspects of the high-performance liquid chromatography (HPLC) system also exhibited shared flaws. At both sites, users could delete raw HPLC data from the local hard drives and did so this year at Chikalthana. Wockhardt claims the data was deleted to clear space on the hard drive. No backups were made. With the shared problems suggesting systemic failings, Wockhardt is now tasked with running a global assessment of its operations--and implementing changes where necessary--to satisfy the FDA.
The Wockhardt warning letter is reminiscent of the situation faced by Hospira in 2010. Both received a warning letter covering flaws at one plant, failed to make networkwide improvements and subsequently were sent a follow-up detailing problems at multiple facilities. In both cases this second warning letter called for a comprehensive and global evaluation of manufacturing operations to ensure they all meet cGMPs and other FDA requirements. Hospira is still trying to bring its plants up to scratch three years later.
- here's the warning letter
- check out FiercePharma's take
- and Bloomberg's coverage