FDA 483 - Pharmaceutic Labs, LLC. - September 23, 2015

An FDA inspection of Pharmaceutic Labs, LLC., an outsourcing facility in Albany, NY, was conducted from August 31 to September 23, 2015. The inspection resulted in a Form FDA 483, highlighting six significant observations concerning the firm's sterile drug product manufacturing and quality control. Main issues included the absence of established procedures to prevent microbiological contamination, specifically regarding dynamic cleanroom certifications, and inappropriate personnel attire due to inadequately validated sterilization of multi-use goggles.

Further violations involved a lack of comprehensive written test procedures for sterility and insufficient laboratory controls. This was evidenced by the absence of 100% visual inspection for repackaged sterile Avastin syringes, a lack of trained personnel for visual inspection, and missing specifications for incoming materials. Additionally, equipment used for visual inspection was found to be unsuitable due to surface damage, and the firm lacked a written program and supporting stability data for the 90-day Beyond Use Date assigned to repackaged Avastin.

These observations indicate non-compliance with regulatory expectations for sterile drug product manufacturing and quality assurance. As per the regulatory framework for an FDA 483, Pharmaceutic Labs, LLC. is required to provide a written response to the FDA detailing corrective and preventive actions to address these deficiencies and ensure adherence to good manufacturing practices.