FDA 483 - Phamedica Inc. - January 10, 2020

Phamedica Inc., a medical device manufacturer in Plainview, NY, received a Form FDA 483 citing two significant observations. The firm failed to maintain adequate written Medical Device Reporting (MDR) procedures, specifically lacking electronic MDR (eMDR) procedures for serious incidents and timely reporting. Additionally, process validation was inadequately documented, with missing serial numbers for materials and calibration records for test equipment.