FDA 483 - Carroll-Baccari, Inc. - October 16, 2019

An FDA inspection of Carroll-Saccari, Inc., a medical device manufacturer, revealed significant quality system deficiencies. The firm failed to adequately establish procedures for finished device acceptance, labeling control, nonconforming product, complaint handling, and Medical Device Reporting (MDR), including a failure to report an adverse event involving Burkholderia cepacia contamination. Additional issues were noted in process controls, equipment maintenance, purchasing, corrective and preventive actions, training, and document control, indicating a broad lack of adherence to regulatory requirements.