FDA WARNING_LETTER - Avacen Inc. - July 25, 2013

On October 23, 2013, the FDA issued a Warning Letter to Avacen, Inc. following an inspection from July 24-25, 2013. The inspection revealed that Avacen's product, The Avacen Thermal Exchange System (TATES), is an adulterated device under section 501(h) of the Act, as its manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: - Failure to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a)). - Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a)). - Failure to maintain complaint files and establish adequate complaint handling procedures (21 CFR 820.198(a)). The provided procedure dated 7/24/2013 was deemed inadequate. - Failure to establish and maintain procedures for acceptance activities (21 CFR 820.80(a)). - Failure to establish and maintain adequate purchasing control procedures (21 CFR 820.50). - Failure to establish and maintain procedures for Device History Records (DHRs) (21 CFR 820.184). - Failure to establish and maintain adequate procedures