FDA 483 - Impax Laboratories, LLC. - February 28, 2013

This FDA Form 483 document details observations from an inspection, indicating several deficiencies in the facility's operations and quality systems.

**Test Methods and Quality Control:** * The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established. * Non-suitable test methods are used for releasing finished drug products. * Test methods are not formally validated or determined acceptable prior to use in the QC laboratory. * Reports of analysis from component suppliers are accepted without validating the reliability of their analyses.

**Manufacturing Process and Controls:** * Control procedures are not established to validate manufacturing process performance, leading to variability in in-process material and drug product characteristics. * Inadequate controls over computer systems allow unauthorized changes to master production and control records. * Batch production and control records lack complete information.

**Documentation and Procedures:** * Written cleaning and maintenance procedures lack sufficient detail regarding methods, equipment, materials, disassembly/reassembly, and operational parameters. * Annual reports do not include a full description of manufacturing and control changes. * Written procedures for warehousing drug products are not followed. * Written procedures for annual product evaluations (including complaints, recalls, returns, and investigations) are not followed.

**Personnel and Storage:** * Employees involved in manufacturing and processing lack the required training and experience. * Drug products are not stored under appropriate humidity conditions, potentially affecting identity