FDA WARNING_LETTER - Circulatory Technology Inc - March 15, 2010

During an inspection from March 9-15, 2010, the FDA determined that Circulatory Technologies, Inc. manufactures the "Bigger Better Bladder" device. The device was found to be 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 CFR Part 820).

Violations include: 1. Failure to establish and maintain adequate procedures for corrective and preventive action (21 CFR 820.100(a)(1)). 2. Failure to establish and maintain procedures for design changes, including validation and acceptance criteria (21 CFR 820.30(i)). 3. Failure to establish and maintain procedures for evaluating and selecting suppliers, contractors, and consultants (21 CFR 820.50(a)(1)). 4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)).

The device was also misbranded under 21 U.S.C. 352(t)(2) for failing to furnish required information under 21 U.S.C. 360i. Specific misbranding violations include: 1. Failure to develop, maintain