COMPANY'S QUALITY CONTROL UNIT FAILED TO INVESTIGATE PROBLEMS, FDA SAYS

The FDA has cited Actavis Totowa for deficiencies with its quality control unit, including a failure to investigate out-of-specification test results and to record all data.

Because of the current good manufacturing practice violations observed during agency inspections July 10 to Aug. 10, 2006, the company's prescription drug products are adulterated, according to a warning letter sent Feb. 1 and posted to the FDA's website recently.

Actavis Totowa responded to the FDA five times with promised corrective actions and a quality system improvement plan, the Feb. 1 letter said. Although the responses adequately addressed many of the cited violations, the FDA said it is concerned with the quality of the company's distributed drug products and suggested the company hire a third party to conduct a quality system audit.

Most of the cited problems involved the company's quality control unit. The unit failed to investigate and resolve laboratory deviations and out-of-specification test results, the letter said. Instead, employees retested the products and distributed them without any explanation for discarding the original out-of-specification data, according to the warning letter.

The FDA also said the quality control unit failed to include all test data, including out-of-specification data, in laboratory notebooks. In addition, the team did not document problems in investigation reports until several weeks after the problems had occurred. The unit also failed to routinely check electronic data files for accuracy.

Actavis Totowa did not respond to a request for comment by press time.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6235d.pdf ( http://www.fda.gov/foi/warning_letters/g6235d.pdf ).