Abbott gets manufacturing quality warning at diagnostics site
This article was originally published in Clinica
Executive Summary
Abbott Molecular has been warned by the US FDA of poor manufacturing standards at its Des Plaines, Illinois facility where it makes molecular diagnostics products. The warning letter, dated August 12 but released on November 17, stems from an inspection carried out June 2-29 2009. The investigation found inadequacies in the way the company evaluated finished tests and highlighted flaws such as contaminated PCR plates. The letter says that the company’s response to this issue was “inadequate” and failed to address underlying design issues. Instead, the firm attempted to “justify the potential for low-level contamination”. Abbott said it had “already taken a number of steps to address items outlined in the letter”.