FDA WARNING_LETTER - Insert Depot, Inc - November 19, 2013

On January 29, 2014, the FDA issued a Warning Letter to Insert Depot, Inc. following an inspection from November 7-19, 2013, which found their Tony Riso 25/30 Multifunction Ultrasonic Scaler to be an adulterated medical device. The firm's manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

The FDA acknowledged the firm's assurance to cease manufacturing and distributing new devices but deemed their December 9, 2013, response inadequate due to a lack of documentation for corrections and no subsequent monthly updates.

Key violations included: 1. Failure to adequately establish complaint handling procedures (21 CFR 820.198(a)), with specific examples of uninvestigated complaints. 2. Failure to establish and maintain design control procedures (21 CFR 820.30(a)). 3. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)). 4. Failure to establish and maintain procedures for acceptance activities (21 CFR 820.80(a)). 5. Failure to maintain an adequate device master record (DMR) (21 CFR 820.181).