Eon Labs Inc – FDA 483, Jun 22, 2011

This FDA Form 483 details multiple deficiencies at a pharmaceutical manufacturing facility in Wilson, NC.

**Quality System and Manufacturing Issues:** The Quality Control Unit's responsibilities and procedures are not fully followed, lacking overall oversight to ensure validated processes before commercial release. Products like Benazapril, Labetalol, Lovastatin, and Methimazole were released after compression on tablet presses that were not validated, despite only one press being validated during the process.

**Production and Process Control Deficiencies:** There are no written procedures for production and process controls to assure drug product identity, strength, quality, and purity. Finished drug products were released without validated processes, specifically for products compressed on unvalidated tablet presses.

**Statistical Process Control and Validation Issues:** Control procedures for DSC manufacturing processes are not established to validate performance. The Statistical Process Control (SPC) system (SOP v-029) is deficient due to incorrect application of statistical process control, including erroneous estimation for control charts, incorrect use of constant A, and incorrect calculation of control limits for tablets. Individual tablet weights are not recorded for weight variation, instead total tablet weight is used. An impurity from a food-grade bag was identified. Blend homogeneity was not achieved during process validation for capsules, leading to a recommendation that capsules not be considered validated. The manufacturing process during process validation for capsules differed from what was submitted to the FDA.

**In-Process Material Examination and Testing:** Blend