Auric Enterprises, Inc. D.B.A. Diack – FDA Warning Letter, Jul 30, 2015

On September 3, 2015, the FDA issued a Warning Letter to Auric Enterprises, Inc. (d.b.a. Diack) following an inspection from June 15-17, 2015, and July 30, 2015. The inspection determined that the firm manufactures Diack and VAC sterilization monitors, which are classified as devices under the Federal Food, Drug, and Cosmetic Act. The devices were found to be adulterated because their manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

The Warning Letter cited several violations: 1. Failure to establish and maintain corrective and preventative action (CAPA) procedures (21 CFR 820.100(a)), evidenced by the absence of procedures and failure to document investigation and CAPA for quality issues with supplier sulfur. 2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198), as no such procedures were available. 3. Failure to develop, monitor, and control production processes to ensure device conformity to specifications (21 CFR 820.70(a)), exemplified by the use of expired Zinc Stearate and Methyl Red in a Diack powder batch. 4. Failure to establish