The FDA has come down on a small New Jersey drugmaker for taking a skin medication to market even though there were out-of-specification (OOS) tests when it was released and during two stability tests.
The FDA in a warning letter reprimanded Teligent’s plant in in Buena, New Jersey, for not thoroughly investigating the OOS results in clobetasol propionate cream, a corticosteroid used to treat skin conditions such as eczema.
At release testing, the plant twice got OOS results before finally getting a passing result, the letter says. Teligent blamed the variations on “lot-specific sample interaction,” but the FDA said there was no real basis for that finding. The drug also failed stability tests at nine months and 18 months, but Teligent took no market action.
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There also were OOS issues with other drugs, and the plant was not testing drugs within the time frames set in its own written procedures. The FDA, unhappy about these lapses, told Teligent get an independent, retrospective review of all invalidated test results for products currently on the U.S. market that haven’t expired.
It also wants the drugmaker to lay out exactly what it intends to do going forward to make sure it conducts thorough investigations into the root causes when drugs do not meet standards.
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While the inspection that resulted in this warning letter occurred last spring, the plant is slated to be visited again soon by the FDA for preapproval inspection. The company recently submitted a prior approval supplement for ranitidine hydrochloride injection. It would be the first drug to come out of its recently expanded sterile operations at the Buena plant.
Because the FDA has recently said many ranitidine drugs have been found to have unacceptable levels of the suspected carcinogen NDMA, Teligent said it has done additional testing to make sure NDMA in its injection does not exceed those levels.
