FDA WARNING_LETTER - altasource llc - July 20, 2012

On July 17-20, 2012, the FDA inspected Meta Labs LLC's dietary supplement and cosmetic facility in Roswell, GA, revealing serious violations. The inspection found that dietary supplement products were adulterated under 21 CFR Part 111 due to CGMP violations.

Specifically, the firm failed to: * Make and keep written procedures for quality control operations (21 CFR 111.140(b)(1)). * Establish and follow written procedures for returned dietary supplements, and failed to quarantine them (21 CFR 111.503, 111.510). * Prepare and follow a written master manufacturing record (MMR) for each unique formulation and batch size (21 CFR 111.205(a)). * Keep records documenting why tests ensure product specifications are met (21 CFR 111.95(b)(4)). * Prepare a batch production record for each batch (21 CFR 111.255(a)). * Establish laboratory control processes reviewed by quality control, including criteria for standard reference materials (21 CFR 111.315(d)). * Make and keep records of written procedures for manufacturing operations (21 CFR 111.375(b)).

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