FDA WARNING_LETTER - Tra & Accessories - September 27, 2010

On February 1, 2011, the FDA issued a Warning Letter to Tra & Accessories, a manufacturer (specification developer, repacker/relabeler) of Tono-Pen Tonometer Tip Covers. An inspection from September 8-27, 2010, revealed the devices are adulterated and misbranded.

Violations of the Quality System (QS) regulation (21 CFR Part 820) include: 1. **Design Control (21 CFR 820.30(a)):** Failure to establish and maintain adequate design control procedures, lacking documentation for design input, output, review, verification, validation, changes, and a design history file. Only a "blue print" drawing was maintained. 2. **Purchasing Controls (21 CFR 820.50(a)):** Failure to establish requirements for suppliers (e.g., Profound Rubber Industries) and lacking quality documents or agreements for supplier qualification. 3. **Environmental Control (21 CFR 820.70(c)):** Failure to control environmental conditions where products are exposed to an uncontrolled warehouse environment during receiving and repackaging. 4. **Incoming Product Acceptance (21 CFR 820.80(b)):** Failure to establish procedures and criteria for incoming product acceptance, including a statistically valid sampling plan. 5. **Equipment Maintenance (2