FDA EIR - InvaGen Pharmaceuticals, Inc. - March 30, 2017

An FDA inspection of InvaGen Pharmaceuticals, Inc. in Hauppauge, NY, conducted from March 20-30, 2017, identified three significant violations of regulatory standards governing drug manufacturing. The inspection was carried out under the framework of Drug Manufacturing Inspections (7356.002) and the DQRS Drug Quality Reporting System (7656.021A), focusing on adherence to current Good Manufacturing Practices (cGMP). The primary issues observed included a failure to maintain backup files for data from Programmable Logic Controllers (PLCs) used in drug manufacturing, with alarms not documented and software validation lacking assessment of memory limits. Secondly, the firm demonstrated inadequate controls over its computerized systems, specifically a particle size analysis system, where analysts could delete test and program files, compromising data integrity and not meeting open system control requirements for trustworthiness and reliability. Lastly, InvaGen Pharmaceuticals failed to properly retain control and labeling records, with crucial documents like daily balance calibration records and in-process product status labels found discarded. Additionally, logbooks were not securely bound, allowing for easy page removal. Mr. Nikhil Lalwani, Chief Executive Officer, acknowledged these deficiencies, committing to implementing corrective actions. The company is required to submit a written response to the FDA within 15 business days following the inspection, with a stated goal to rectify the observations within three months.