FDA WARNING_LETTER - DreamLife, LLC - June 08, 2011

On June 3 and 8, 2011, the FDA inspected DreamLife, LLC, revealing serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). The inspection resulted in a FORM FDA 483, indicating adulterated dietary supplement products.

Key violations include: 1. Failure to establish product specifications for contamination limits and verify finished batches meet specifications (21 CFR 111.70(e), 111.75(c)). PowerGum batches lacked identity, purity, strength, and composition testing. 2. Master Manufacturing Records (MMR) for PowerGum lacked controls, complete component lists, documentation of component weights, identity/weight of dietary ingredients, specifications for manufacturing stages, sampling procedures, verification instructions for component addition, corrective action plans, and packaging descriptions/labels (21 CFR 111.205(b)(2), 111.210). 3. Failure to maintain, clean, and sanitize contact surfaces; extruder equipment had leftover remnants from April 2011 manufacturing (21 CFR 111.27(d)). 4. Failure to collect and retain representative samples of finished dietary supplement batches before distribution (21 CFR 111.80(c), 111.83(b)(3)). 5. Failure