FDA issues untitled letter to Wockhardt's new sterile injectables plant

A new sterile injectables plant for which India's Wockhardt is seeking FDA approval has been written up in an untitled letter.

It turns out the FDA warning letter India's Wockhardt reported last week for a plant in the U.S. is the second regulatory whipping for the drugmaker this year. A sterile injectables plant that Wockhardt is trying to get approved by the FDA has been issued an untitled letter.

The letter, obtained by FiercePharmaManufacturing, was issued January 26 to Wockhardt’s sterile injectables plant in Shendra, a facility that has yet to be approved to ship products to the U.S. In it the FDA noted some of the same data integrity issues that the agency documented in the warning letters to other Wockhardt plants.

While warning letters are issued for violations the FDA expects to be dealt with immediately, untitled letters serve more as an initial notice to a company of processes that need tweaking before a more serious action is required. The problems had been noted during an initial inspection of the plant in January 2016. In the untitled letter, the FDA acknowledged Wockhardt is working to address its concerns but said it was still not satisfied with the company’s efforts.

It said, for example, that Wockhardt had not fully investigated the cause of 22 failings on a sterile line, failings that might say something about the sterility of drugs. It said operators assumed equipment errors and retested the batches and then deleted the failed test results, a violation of the FDA's procedures.

There were several lapses in data integrity. There were deleted test results found in the trash, while a “large bag of unaccounted-for shredded documents,” some marked with quality assurance stamps, were found next to a shredder in the microbiology testing lab. 

The Indian drugmaker is counting on the new plant to help it restore its U.S. business. Sales to the U.S., its largest market, have been crushed by a series of six warning letters for seven Wockhardt plants, three of which have been banned from shipping to the U.S.  Last week, Wockhardt reported it has received a warning letter for its Morton Grove Pharmaceuticals plant in Illinois.