FDA 483 - Sarasota Medical Products, Inc. - June 12, 2019

Sarasota Medical Products Inc, a medical device manufacturer in Sarasota, FL, was inspected by the FDA. The inspection revealed significant deficiencies in process validation for sterilization, particularly for HTLA Hydrocolloid adhesive products, as well as inadequate procedures for Medical Device Reporting (MDR). Additionally, device history records were found to be incomplete, indicating a lack of adherence to quality system requirements.