FDA WARNING_LETTER - TOADS LLC - November 28, 2012

On February 22, 2013, the FDA issued a Warning Letter to TOADS, LLC, following an inspection from October 30 to November 28, 2012, at their Louisville, Kentucky facility. The inspection revealed that TOADS, LLC, which manufactures Orthodontic Temporary Anatomical Anchor Device Systems (TAADS), was not in conformity with the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: - **Design Change Control (21 CFR 820.30(i)):** Approximately (b)(4) design changes were made without documented validation activities, including a TAAD Mini Anchor appearing to be a different design from the cleared 510(k) (K063149). - **Purchasing Controls (21 CFR 820.50(a)):** The firm failed to ensure its contract manufacturer validated the manufacturing process for TAADS. - **Design Input (21 CFR 820.30(c)):** Design input requirements were not clear, specific, measurable, or approved by management. - **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Customer feedback was not documented