FDA EIR - InvaGen Pharmaceuticals, Inc. - December 06, 2019

An FDA routine Good Manufacturing Practice (GMP) surveillance inspection of InvaGen Pharmaceuticals, Inc., a non-sterile generic prescription drug manufacturer in Hauppauge, NY, was conducted from December 2-6, 2019. The inspection, carried out under the regulatory framework of CP7356.002-Drug Manufacturing Inspections, aimed to ensure general GMP compliance, follow up on Field Alert Reports, Drug Quality Reporting System complaints, and review corrective actions from a previous inspection. The inspection resulted in a three-item Form FDA 483, identifying significant violations. Firstly, the company failed to ensure appropriate laboratory determination and satisfactory conformance to final specifications before releasing drug products. This was highlighted by the release of Warfarin Sodium Tablets using incorrect Lisinopril USP analytical data and a monthly, rather than pre-release, audit trail review of analytical results. Secondly, written procedures for in-process controls, tests, and examinations were not followed, such as operators failing to collect adequate tablet samples and not fully documenting calculations in batch records during manufacturing. Lastly, batch production and control records were found deficient in documenting significant manufacturing and processing steps. InvaGen Pharmaceuticals' management acknowledged these observations and agreed to submit a formal response to the FDA within 15 business days, outlining their corrective and preventive actions.