The FDA warned sterile drug manufacturer PharmScript for adulterated products and insanitary conditions at its Somerset, N.J., facility.
The agency initially issued a Form 483 after a 2016 inspection revealed inadequate conditions for sterility, but it was not satisfied with the company’s response because it lacked supporting documentation.
The FDA inspectors found that the facility was not properly designed for sterile drug production, and the firm could not demonstrate that it was providing acceptable protection for the ISO 5 cleanroom where sterile products were processed. In addition, the facility’s disinfection program used a non-sterile disinfectant for aseptic processing areas.
PharmScript suspended drug operations in response to the 483. In the warning letter, the agency suggested the firm hire a third-party consultant and conduct a comprehensive assessment of operations if it decided to resume sterile drug production.