According to a warning letter published this week the San Antonio, Texas-headquartered firm failed to identify sterility failures that affected six lots of Santyl Ointment produced at its manufacturing facility in Lakewood, New Jersey.
The regulator said the investigation – which attributed the problems to the unnamed contract lab DPT worked with at the time, the use of the cap puncture testing method and contamination of water baths used to conduct analysis – was inadequate.
The FDA also criticised DPT’s decision to release lots of the ointment despite detecting bacterial contamination in media samples, arguing that the conclusion that “inadequate aseptic technique by an operator” was responsible did not rule out all possible sources.
“The Bacillus species identified is a ubiquitous environmental organism that could have been introduced into the aseptic area via multiple sources. Nevertheless, you failed to consider other sources of contamination in your investigation.”
The agency also expressed concerns about DPT’s efforts to address the problems, suggesting that initiatives like random environmental sampling or personnel and using sterile probes to puncture sample tubes during testing may not be enough.
“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, and the clean area classification.”
In a statement emailed to Outsourcing-pharma.com DPT said that: "Management is committed to working with the FDA to resolve this issue, and is in the process of developing a well thought out response and corrective action plans."
The firm added that it "has engaged outside regulatory consultants to support our response and interaction with the FDA on this matter."
DPT was purchased by Renaissance Pharma from DFB Pharmaceuticals in July.