The analysis that FDA’s Center for Drug Evaluation and Research (CDER) is conducting to lay the foundation for a more comprehensive assessment of a manufacturer’s quality assurance (QA) capabilities is showing that the results of one inspection are not a reliable predictor of the outcome of a subsequent inspection at the same facility.
The review of FDA inspection results indicates, for example, that a “no action indicated” (NAI) finding in some cases has been followed in less than a year by an inspection that uncovers issues serious enough to warrant an “official action indicated” (OAI) classification for the facility and a warning letter.
CDER’s Office of Surveillance, which will operate under the Office of Pharmaceutical Quality (OPQ) when it begins operations in January, will be spearheading the agency’s effort to find reliable predictors of the state of quality in a firm.
At the annual APIC/CEFIC API conference, held in Vienna, Austria in early November, the incoming head of OS, Theresa Mullin, reported on how the office is taking shape, its purview, its mission, and the initiatives that it will be driving as its operations get underway. Mullin is currently director of CDER’s Office of Strategic Programs.