FDA WARNING_LETTER - Urban Moonshine, Inc. - December 16, 2013

On November 20, 2014, the FDA issued a Warning Letter to Urban Moonshine, Inc. following an inspection from December 4-16, 2013. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering products like Nettles, Milky Oats, and Immune Zoom adulterated.

Key violations include: 1. **Failure to establish finished product specifications (21 CFR 111.70(e))**: Specifications for Immune Zoom were inadequate, only covering physical attributes and not identity, purity, strength, composition, or contamination limits. The firm's response was insufficient. 2. **Failure to establish component specifications (21 CFR 111.70(b))**: No identity specifications for Immune Zoom components, nor purity, strength, composition, or contamination limits for components in Nettles, Milky Oats, or Immune Zoom were established. The firm's response was inadequate. 3. **Failure to prepare and follow unique Master Manufacturing Records (MMRs) (21 CFR 111.205(a))**: The MMR for Immune Zoom was generic and used for other products, lacking product and batch-size specificity. The firm's response did not address this. 4. **Failure to include complete information in batch production records (21 CFR 1