FDA 483 - KBD, Inc. - November 08, 2019

KBD, Inc. DBA Sperti Sunlamps in Las Vegas, NV, a medical device specification developer, received a Form FDA-483 with 15 observations related to significant deficiencies in its quality system and product labeling. The inspection revealed widespread issues including a lack of established design history files, inadequate design change procedures, insufficient complaint handling, and absent CAPA effectiveness verification. Additionally, the firm failed to properly evaluate suppliers, establish acceptance activities, maintain device master records, and ensure correct labeling for its sunlamp products, indicating a systemic breakdown in quality management and regulatory compliance.