FDA warns Teva (again) on propofol plant

Teva has just taken the lead for the Tempting Fate award. The Israeli-based generics maker received an FDA warning letter in December, after submitting six separate responses to the regulator following violations identified in a July inspection of a parenteral medicines manufacturing facility in Irvine, CA.

"We have received your firm's responses... and note they lack sufficient corrective actions," the letter says.

The FDA has indicated that its patience has been worn thin by manufacturers that promise to fix GMP violations but then don't deliver. The regulator has even said that it is willing to pursue misdemeanor prosecutions of the executives responsible.

Among the remaining GMP failures are inadequate testing of the raw materials used in the anesthetic propofol. The FDA notes that Teva promises in three of its responses to the regulator that it will test each lot. "We will evaluate the implementation of this testing... during our next inspection," the regulator promises.

Propofol was the subject of a massive recall last July for suspected bacterial contamination. In the current warning letter--after six Teva responses--the FDA again cites the drugmaker for its "failure to subject each lot of a component with potential for microbiological contamination... to microbiological tests before use."

The lengthy letter addresses 11 additional items for which promised fixes remain inadequate. Among them: batch failure investigations, batch acceptance criteria, equipment validation, equipment cleaning and sanitizing, recordkeeping and written procedures.

The FDA it demands that Teva come up with a plan to bring the facility back into compliance, reports sister publication FiercePharma. Teva says the company plans to shut down the plant this week to address process enhancements.

- see the warning letter

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