Warning letter notes sterility test failures in 6 lots in 2 years
The FDA has raised serious concerns about the sterility procedures at DPT Laboratories' Center of Excellence for Sterile and Specialty Products in Lakewood, NJ, particularly over an ointment intended to help heal skin wounds and burns.
The contract manufacturer, in a statement, says it is working with the FDA to fix its problems. DPT, which in July was acquired by a private equity firm, invested $40 million in an expansion of the plant in 2010 so that it could specialize in aseptic production of sterile dosage meds. But FDA inspectors, during visits in February and March, found problems with microbial contamination and zeroed in on the company's inability to get to the root of the problem, according to a warning letter posted this week on the agency's website. It said that after sterility test failures in 2010 and 2011, the company's response has been to retrain employees in aseptic filling procedures, but that clearly hasn't solved the problem.
The warning letter says that after "the May 2011 sterility failures and then the failed media fill conducted in June 2011, you committed to completing three successful media fills prior to resumption of manufacturing," but the latest lapse indicates that retraining is not the answer.
The warning letter says that after "the May 2011 sterility failures and then the failed media fill conducted in June 2011, you committed to completing three successful media fills prior to resumption of manufacturing," but the latest lapse indicates that retraining is not the answer.
The letter says DPT has seen 6 lots of Santyl Ointment fail release testing since the plant was approved in November 2010. "These sterility failures indicate that your firm does not have adequate aseptic procedures in place." In June 2011, the letter says, a "Bacillus species was identified in the samples incubated for the media fill," and again inspectors were unimpressed with how the company handled the investigation.
Read rest of article at UPDATED: FDA finds DPT's Center of Excellence not so sterile - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-finds-dpts-center-excellence-not-so-sterile/2012-09-06#ixzz25iH6ncrJ
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