FDA WARNING_LETTER - American Spice Trading Company Inc. - June 23, 2014

An FDA inspection of American Spice Trading Company, Inc.'s Miami facility from May 21 to June 23, 2014, revealed serious violations concerning its Pampas brand Lemon Juice. The agency determined the products were adulterated under Section 402(a)(4) of the FD&C Act, having been prepared under insanitary conditions. The warning letter details significant violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 120. Key deficiencies included the failure to include a validated control measure for a 5-log pathogen reduction, omitting microbiological hazards like Salmonella from the HACCP plan, and having an inadequate corrective action plan that used unpermitted ingredients. Additionally, the firm failed to validate its HACCP plan and did not properly implement or monitor sanitation standard operating procedures, as evidenced by a leaking drain pipe and a large gap under a loading bay door that could allow pest entry. The FDA requires the company to take prompt corrective action and provide a written response within 15 working days, warning that failure to comply could result in further regulatory actions such as seizure, injunction, and the assessment of re-inspection fees.