Teva Pharmaceutical Industries Ltd (NYSE:TEVA) has received a warning letter from the Food and Drug Administration (FDA), warning it that it needs to improve manufacturing standards at its sterile injectable plant in Hungary. Unlike on previous occasions where the agency ordered the company to shore up things at the plant, this time it has detailed the key problem areas that need to be worked on.
FDA Warning Letter
The warning letter follows a two-week FDA inspection of the facility earlier in the year where deficiencies in manufacturing operations and laboratory controls were discovered. The agency also raised concerns about the integrity of the company’s data program. Prior to the issuance of the warning letter, the regulator had already banned the company’s two cancer treatment bleomycin and antibiotic amikacin that the facility was developing.
While confirming receiving the warning letter, Teva says it has already started working on the issues raised in a bid to ensure manufacturing levels meet quality and compliance standards.
“Teva has undertaken corrective actions to address both the specific concerns raised by investigators as well as the underlying causes of those concerns. Communication with the FDA is ongoing,” the company in a statement.
Opened in 2012, the Godollo facility has continued to expand the company’s injected drug capacity. Following the issuance of Form 483 by the FDA early in the year, the company was forced to suspend production in a bid to address some of the concerns raised.
Generics and Biosimilar Push
The warning letter could not have come at a worse time, given that the company is in the process of selling a number of units as part of the $40.5 billion Allergan deal. While the acquisition is expected to bolster the company’s prospects in the generic drugs market, pursuing opportunities on biosimilars is also a core objective.
There are already reports that the pharmaceutical company may seek to bolster its biosimilars drugs credentials with the acquisition of South Korea’s Celltrion.
Investors appear to have shrugged off news of the warning letter as Teva rallied by 2.01% in Thursday’s trading session to close at a high of $44.21 a share.