FDA 483 - Impax Laboratories, LLC. - May 04, 2016

During an FDA inspection conducted from April 4 to May 4, 2016, Impax Laboratories, Inc., a pharmaceutical manufacturer in Hayward, CA, received a Form FDA 483 detailing significant observations. The primary issues identified related to deficiencies in equipment cleaning and maintenance, as well as critical gaps in post-marketing adverse drug experience (ADE) reporting.

Specifically, the inspection found that cleaning validation for certain manufacturing equipment, particularly for capsule products and a granulator, was incomplete or not adequately representative. Procedures for routine cleaning verification lacked sufficient detail regarding sampling sites, compromising proper monitoring.

Furthermore, the firm lacked comprehensive written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing ADEs. This included insufficient guidance for all employees on handling ADEs and an absence of clear processes for reconciling ADE data exchanges with business partners. Records of ADE submissions to drug product applicants were incomplete, with one instance showing a significant delay in reporting. Additionally, the review of adverse drug experience information was inadequate, marked by insufficient follow-up investigations and a lack of proper documentation for classifying the seriousness of cases.

These observations indicate potential non-compliance with federal regulations governing drug manufacturing and pharmacovigilance. Impax Laboratories is required to implement corrective and preventive actions to address these deficiencies and ensure compliance with regulatory standards for drug product quality and patient safety reporting.