FDA WARNING_LETTER - arnold tuber industries - July 31, 2009

On July 27-31, 2009, an FDA inspection of Arnold Tuber Industries, LLC dba Sci-Dent, Inc., a manufacturer of aspirating dental injection syringes, revealed significant violations. The devices were deemed adulterated because the firm lacked an approved premarket approval (PMA) or investigational device exemption (IDE) application, and misbranded for failing to submit a 510(k) premarket notification.

The inspection also found the devices adulterated under CGMP requirements of the Quality System (QS) regulation (21 CFR Part 820). Specific violations included: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)). 2. Failure to control design changes, including validation and approval (21 CFR 820.30(i)). 3. Inadequate complaint handling procedures (21 CFR 820.198(a)). 4. Failure to investigate device failures identified in complaints (21 CFR 820.198(c)). 5. Lack of procedures for finished device acceptance (21 CFR 820.80(d)). 6. Failure to validate computer software used in production/quality systems (21 CFR 820.70(i)). 7. Lack of documented maintenance activities (21