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 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.
The inspectors acknowledged DPT's efforts to make changes but said they were not confident that it would solve the problems. "We recommend you conduct a comprehensive evaluation of your sterile drug operations, including but not limited to a thorough review of material flow, personnel practices, production supervision, operational procedures, quality assurance oversight, the training program, room design, equipment suitability, the environmental monitoring program, systems used to investigate contamination events (e.g., media fills, sterility test failures), and the clean area classification."
In July, Renaissance Acquisition Holdings of Lake Forest, IL, acquired DPT for an undisclosed amount of money. Renaissance is a partnership of RoundTable Healthcare Partners and Pierre Frechette, the former CEO of Sabex, that was formed to invest in small to mid-size pharmaceutical companies.
In a statement to FiercePharmaManufacturing, Paul Johnson, DPT, group president and COO, said, "Our priority is the safety and quality of the products we produce. DPT has a strong history of acting in good faith to fully comply with all regulatory obligations. We are working diligently and cooperating completely with the FDA to resolve this matter."
Sterility, always of high concern among regulators, has played a central role in several inspections at North American plants recently. The FDA in lambasted Sanofi Pasteur over sterility concerns at a Canadian vaccine plant recently, and the European Medicines Agency (EMA) last month recalled a drug that is injected into the brain for brain cancer treatment, after inspectors found sterility issues at the Pacira plant in California where it is produced.
- read the FDA warning letter
- here's the acquisition release
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