FDA WARNING_LETTER - Beehive Botanicals, Inc. - July 25, 2012

An FDA inspection of Beehive Botanicals, Inc. from July 23-25, 2012, revealed significant violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products adulterated. The company's August 13, 2012, response to the FDA-483 was deemed inadequate.

Key violations include: 1. **Failure to establish required specifications (21 CFR 111.70):** No component specifications for purity, strength, and composition, and no finished product specifications for identity, purity, strength, and composition. The company's testing methods (e.g., (b)(4)) are insufficient to verify labeled amounts, and no timeframe for correction was provided. 2. **Inadequate test methods (21 CFR 111.75(h)(1)):** The firm uses (b)(4) for identity testing, but reference materials for approximately 80% of ingredients are not confirmed as the purported biological material. The procedure allows analysts to select different comparison lots, and third-party lab results indicated unverified/unvalidated methods. No timeframe for correction was provided. 3. **Incomplete Master Manufacturing Records (MMRs) (21 CFR 111.210):** MMRs lacked specific actions for manufacturing steps (e.g., mixing instructions