India’s Aurobindo, which has yet to meet Federal Trade Commission (FTC) terms to complete a $1 billion deal to buy a significant chunk of Sandoz U.S. generics business, also continues to struggle to meet FDA terms for its manufacturing plants.
The company today reported (PDF) that the FDA issued a four-observation Form 483 following inspections of its API plants at Pashamylaram, Hyderabad, and Gaddapotharam, Hyderabad. It said that the FDA is currently taking a look at its formulation manufacturing facility at Pashamylaram, Hyderabad.
Four observations for two plants does not amount to much, but they do add to a long-running list of concerns that the FDA has expressed during rolling inspections of Aurobindo’s plants.
The FDA earlier this year issued a warning letter to Aurobindo’s facility in the Srikakulam district for issues the FDA said contributed to its valsartan products being tainted with a suspected carcinogen. Last month, the agency issued a citation with seven observations at its key Unit 7 in Telangana after earlier noting problems at two other plants there, a sterile drug plant and a finished dose plant. Those two plants have since had their status upgraded.
Aurobindo has been fighting to get its plants in order even as it has been struggling to satisfy the Federal Trade Commission, which wants the drugmaker to unload some U.S. meds before the agency will allow it to buy 300 products from Novartis’ Sandoz unit. The companies have announced delays several times since the deal was struck more than a year ago, leading some at Sandoz to question whether it will get finalized.
A Novartis spokesperson told FiercePharma last month that both companies are working closely with the authorities, including the FTC.