FDA WARNING_LETTER - Atrium Inc. - January 24, 2012

On January 10-11, 18, and 24, 2012, the FDA inspected Atrium, Inc.'s dietary supplement manufacturing plant in Wautoma, Wisconsin. The inspection and subsequent review of product labeling and websites (www.atriuminc.com, www.nutripakonline.com, www.aspennutrients.com) revealed significant violations.

The products manufactured were found to be adulterated under 21 U.S.C. § 342(g)(1) due to non-compliance with dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Specific CGMP violations included: 1. Failure to establish required specifications for components and finished dietary supplement products (21 CFR 111.70). The company's proposed solutions were deemed inadequate. 2. Failure to prepare written Master Manufacturing Records (MMRs) for each batch size, and MMRs lacked required information such as packaging descriptions, labels, and written instructions for specifications, sampling, and corrective actions (21 CFR 111.205(a), 21 CFR 111.210). The company's response was incomplete, lacking revised MMRs or a timeline. 3. Batch Production Records (BPRs) lacked required information, including equipment identity, cleaning dates, component unique identifiers,