FDA 483 - Tarmac Products, Inc. - September 27, 2019

Tarmac Products, Inc. in Miami Gardens, FL, a manufacturer of OTC drug and medical device products, received a Form FDA 483 with 17 observations. The inspection revealed significant deficiencies in process validation, laboratory controls, data integrity, stability testing, CAPA procedures, equipment qualification and calibration, complaint handling, design control, quality audits, organizational structure, and supplier controls. Many of these issues, particularly regarding laboratory records, stability testing, and quality unit procedures, were repeat observations from previous inspections, indicating a systemic failure to implement effective corrective actions.