Andrx did not properly investigate product discrepancies and out-of-specification results, according to observations listed on the Form 483 the FDA issued to the company after the agency's reinspection of the drugmaker's plant in March.
The FDA had already issued Andrx a Form 483 after an initial inspection of the drugmaker's Davie, Fla., plant in May 2005. As a result of disciplinary action recommended by the FDA's Florida office based on the findings of the first inspection, all of Andrx's pending drug applications have been put on hold.
According to the latest Form 483 obtained by FDAnews through a Freedom of Information Act request, Andrx "failed to perform adequate investigations with scientifically justifiable conclusions to incidents of out-of-specification results or production deviations and/or failed to implement appropriate corrective actions for the root cause determination." In all, FDA inspectors listed nine observations on the Form 483.
For example, the company could not explain how glassware used to test drug compounds had become contaminated. Andrx said its chemists proposed additional cleaning, but the FDA said that Andrx needed to know how the glassware had become contaminated before proposing a solution.
Andrx also failed to clean the plant's equipment and utensils "at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product," the FDA said.
According to the form, Andrx also has not established and documented the accuracy, sensitivity, specificity and reproducibility of methods the drugmaker uses to test its products.
FDA inspectors also said Andrx's quality control division does not have the authority to review production records to make sure no errors have occurred or investigate errors that have occurred. (http://www.fdanews.com/did/5_87/)