FDA WARNING_LETTER - Buchanan Manufacturing Inc - August 16, 2013

On August 13 and 16, 2013, an FDA investigator inspected Buchanan Manufacturing Inc. DBA Grow Agra in Buchanan, Tennessee, and found serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 120). The firm's wheatgrass juice and wheatgrass/carrot juice blend products were deemed adulterated under Section 402(a)(4) of the Act [21 USC 342(a)(4)] due to insanitary conditions.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 120.8(b)(1)):** The HACCP plan failed to list all reasonably likely food hazards, specifically: * Microbiological contamination from reopening containers after high-pressure processing and repacking. * Allergens (wheat), despite labels stating "Allergen Wheat." * Incorrect hazard listed for CCP 2 (Clostridium botulinum, not "pH level above (b)(4)"). 2. **Failure to Ensure 5-Log Reduction and Single Facility Processing (21 CFR 120.24(a) & (c)):** The HACCP plan did not list measures for a 5-log reduction of pertinent microorganisms within a single facility. Products were sent to a separate facility for 5-log reduction and then returned for