FDA scrutiny is focused on a Memphis biologics manufacturer that has had issues with contamination.
In a warning letter posted to the FDA website this week, inspectors said Edge Biologicals' practices are falling short on multiple fronts. Edge makes Mueller Hinton and Thayer Martin Agar products. Mueller Hinton Agar is a microbiological growth medium that is commonly used for testing antibiotic susceptibility.
The agency says Edge's corrective and preventive action (CAPA) procedures failed to adequately document the cause of contamination reported in UVM media on four occasions in 2010. While Edge claimed in its CAPA that the contamination had resulted from "technique" and took steps to change its filling process, the FDA says there is no documentation of the company actually investigating to be sure that was the cause and that changes would prevent further problems.
But that is just the beginning of the FDA's concerns. The agency faults Edge on an unsophisticated complaint-handling process. It says 32 "complaints documented bacterial and/or mold contamination" but there is no indication, other than verbal assurances to inspectors, that all of the products in the lot were examined for contamination. Inspectors also were unimpressed that the complaints were documented on credit-replacement forms instead of complaint forms.
The company also is faulted for failure to clean its equipment on a regular schedule. Additionally, inspectors found product throughout the plant that was not properly identified to prevent mix-ups. "Tubes of Tetrathionate, Tryptic Soy and Urea Broths were stored on unlabeled shelves in the production area with no documentation to identify their acceptance status," the warning letter reads.
Edge has responded to FDA concerns but the agency is not yet satisfied.
- here's the FDA warning letter
Special Report: Fierce's 2011 warning letters report