Able Laboratories, Inc. – FDA 483, Jul 1, 2005

An FDA inspection of Able Laboratories, Inc., a generic pharmaceutical manufacturer in Cranbury, NJ, conducted from May 2 to July 1, 2005, identified significant violations of Current Good Manufacturing Practice (cGMP) regulations. The primary issues stemmed from a critical breakdown in the company's Quality Control Unit and laboratory practices. The Quality Unit lacked the authority and oversight to properly investigate errors, leading to the release of drug products that did not meet specifications. Inspectors found a pattern of routine resampling, retesting, and reprocessing of drug product samples to achieve passing results, often without adequate investigation or documentation of initial out-of-specification (OOS) findings. This deceptive practice extended to the submission of erroneous data in annual reports and prior approval supplements to the FDA, and a failure to submit required Field Alert reports for non-compliant batches. Laboratory records were incomplete, revealing instances of data manipulation, such as altering chromatograms and sample weights, and changing processing methods to mask OOS results. Furthermore, the firm lacked proper accuracy checks for computer-generated data, failed to conduct written investigations into discrepancies, and provided inadequate training to quality control analysts. These extensive failures in quality control and data integrity resulted in the company halting manufacturing and distribution, initiating a recall of all 3,184 distributed drug product batches, and withdrawing at least five abbreviated New Drug Applications. Able Laboratories is required to implement comprehensive corrective and preventive actions to rectify these systemic issues and ensure product safety, identity, quality, and purity.