FDA WARNING_LETTER - Aubrey Inc. - February 04, 2011

On May 16, 2011, the FDA issued a Warning Letter to Aubrey Inc. following an inspection from January 31 to February 04, 2011, at their Carlsbad, California facility. The inspection revealed that Aubrey Inc. manufactures AWBAT (Advanced Wound Bioengineered Alternative Tissue) devices, which are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act because their manufacturing, packing, storage, or installation methods do not conform to the Current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The letter details multiple violations, including: 1. Failure to ensure the device conforms to defined user needs and intended uses (21 CFR 820.30(g)), specifically lacking objective evidence for AWBAT's (b)(4) shelf life. 2. Failure to adequately verify design output meets design input requirements (21 CFR 820.30(f)), lacking data for AWBAT's performance after exposure to specified storage and shipping conditions. 3. Failure to validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), specifically lacking sterilization validation data for a (b)(4) day post-processing timeframe for e-beam sterilization. 4.