FDA slaps DPT with warning letter over sterility concerns

The FDA found sterility issues at DPT Laboratories' Center of Excellence for Sterile and Specialty Products, and the agency said DPT hasn't done enough to prevent future problems.

According to an FDA warning letter, the agency found problems with microbial contamination in an inspection of the CMO's New Jersey facility earlier this year, affecting DPT's Santyl Ointment for wound care. The FDA found similar problems in 2010 and 2011, and the agency writes that DPT's repeated sterility failures "indicate that your firm does not have adequate aseptic procedures in place."

DPT COO Paul Johnson said the company acknowledges the FDA's concern and is working with the agency to solve the problem. "Our priority is the safety and quality of the products we produce," Johnson told FiercePharmaManufacturing. "DPT has a strong history of acting in good faith to fully comply with all regulatory obligations."

The FDA commended DPT for trying to address the issue, but says the CMO didn't go far enough. The agency suggests it conduct a comprehensive evaluation of its 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," according to the letter.

- check out the FDA warning letter
- read Outsourcing-Pharma's take
- get more from FiercePharmaManufacturing

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