FDA 483 - Edlaw Pharmaceutical, Inc. - November 27, 2019

An FDA inspection of Edix Pharmaceutical, Inc., a medical device repackager and relabeler in Farmingdale, NY, revealed significant deficiencies in their quality system. The firm failed to maintain written Medical Device Reporting (MDR) procedures and did not perform quality internal audits at defined intervals. These issues indicate a lack of adequate controls for adverse event reporting and overall quality system oversight.