FDA EIR - AptaPharma Inc. - March 16, 2018

An FDA pre-approval inspection of Apta Pharma Inc. in Pennsauken, NJ, was conducted from March 6 to March 16, 2018. This inspection focused on Abbreviated New Drug Application (ANDA) 210602 for Ibuprofen 100mg Suspension, covering quality, laboratory, production, equipment, facility, material, and packaging/labeling systems. The inspection identified several deficiencies, documented in an FDA Form 483. Key issues included incomplete laboratory records for reference standard testing and standardization, and inadequate control procedures for monitoring and validating manufacturing processes to ensure consistent product characteristics. Additionally, the company lacked a robust system to track drug product distribution for potential recalls and failed to adequately control electronic data to prevent alteration or deletion. Verbal observations noted inaccurate statements of fact and errors within the regulatory submission itself. Management, including the Director of Quality and Vice Presidents, acknowledged these observations and committed to implementing corrective actions. These actions include providing a written response to the FDA, completing process validation for commercial batches, chemically analyzing product uniformity, and finalizing product labeling with distributor information to ensure proper post-market reporting and recall capabilities. The inspection underscored the need for enhanced control over data integrity and manufacturing processes to meet regulatory requirements.