The US Food and Drug Administration (FDA) recently warned a hemodialysis manufacturer for marketing their products without submitting a premarket notification for one of its products and a diagnostics firm for good manufacturing practice (GMP) and quality system issues.
Edge Biologicals
In a warning letter sent to Memphis, TN-based Edge Biologicals, FDA states that the company, which makes class I and class II in vitro diagnostics (IVDs) for medical applications, has repeatedly failed to adhere to good manufacturing practices. Agency inspectors investigated the company’s facilities between 20 March and 4 April and observed several repeat violations seen during previous inspections in 2015 and 2018, as well as repeat issues cited in a 2012 warning letter.
“You failed to validate the cleaning process for controlled environmental areas used for the aseptic processing of Mueller Hinton Agar antimicrobial susceptibility test culture media and other culture media devices,” said FDA. The company was also cited for failing to validate sterilization of tubing sets used in aseptic fill operations for culture media devices.
Among the other violations, Edge Biologicals was cited for failing to establish proper corrective and preventive action (CAPA) procedures, as well as procedures to ensure suppliers, contractors, and consultants meet their requirements. The company was given 15 business days to respond to the agency about the steps it is taking to bring itself into compliance…
