FDA 483 - LTS Therapy Systems, LLC - January 31, 2019

Tapemark Company, a drug manufacturer in Saint Paul, MN, was cited for significant deficiencies in its quality control unit during an FDA inspection. Observations included failures to adhere to procedures for Corrective and Preventive Actions (CAPA) and Non-Conformance Management (NCM), as well as an inadequate product recall procedure. These issues indicate a lack of adherence to established quality system requirements.