Talisman Limited – FDA Warning Letter, Nov 12, 2009

On March 11, 2010, the FDA issued a Warning Letter to Talisman Ltd. following an inspection from November 2-12, 2009. The inspection revealed that the firm's Automated Blood Grouping and Antibody Test Systems, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation (21 C.F.R. Part 820).

The FDA found Talisman Ltd.'s December 4, 2009, and March 5, 2010, responses inadequate as they did not address all observations from the FDA-483. Violations included: 1. Failure to justify not reporting corrective/removal actions to FDA for distributed software patches (21 C.F.R. § 806.20(b)(4)). 2. Failure to establish procedures for conducting quality audits, specifically lacking validation evidence for manufacturing software (21 C.F.R. § 820.70(i)). 3. Failure to have complete and implemented design control procedures, with the SOP not fully addressing design plan and input requirements (21 C.F.R. § 820.30(a)).