FDA EIR - InvaGen Pharmaceuticals, Inc. - March 13, 2012

An FDA inspection of InvaGen Pharmaceuticals, Inc., a generic prescription drug manufacturer in Hauppauge, NY, was conducted from February 23 to March 13, 2015. The comprehensive inspection assessed compliance with Current Good Manufacturing Practices (cGMP), Postmarketing Adverse Drug Experience (PADE) reporting regulations, and included pre-approval inspections for specific Abbreviated New Drug Applications (ANDAs).

The inspection resulted in an FDA-483 with five observations. Key issues included the firm's failure to adequately evaluate systems and procedures stemming from customer complaints, laboratory failures, and deviation notices. Deficiencies were also noted in establishing written procedures for monitoring environmental conditions and ensuring proper storage of materials. Inadequate cleaning validation studies for laboratory glassware were identified, a recurring concern. Furthermore, the firm failed to timely submit 15-day serious and unexpected adverse drug experience reports, as well as quarterly periodic adverse drug experience reports.

Management acknowledged these findings and committed to providing a written response within 15 business days. Despite the observations, a recommendation of "Acceptable" was submitted for the manufacturing of ANDA 206674 (Bupropion HCl Extended-Release Tablets) and ANDA 208200 (Vilazodone HCl Tablets) at the inspected site. No refusals were encountered, and no samples were collected. The report highlights the need for InvaGen to strengthen its quality systems, particularly in investigation effectiveness and adherence to reporting timelines.