FDA 483 - Geri-Care Pharmaceuticals Corp. - May 05, 2025

Geri-Care Pharmaceuticals Corp., an OTC drug repackager and distributor in Lakewood, NJ, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to implement adequate supplier qualification, lacked a written stability program, and did not thoroughly investigate deviations or customer complaints. Additionally, the company did not perform annual visual inspections of reserve drug product samples.