Alabama Sunshine, Inc. – FDA Warning Letter, Jul 13, 2011

On July 11-13, 2011, an FDA inspection of Alabama Sunshine, Inc., a manufacturer of acidified foods (hot sauces, relishes, salsas), revealed significant deviations from federal regulations, causing products to be adulterated under 21 USC 342(a)(4).

Violations included: 1. Failure to file scheduled processes for each acidified food product and container size with FDA (21 CFR 108.25(c)(2)). 2. Failure to establish scheduled processes using a qualified acidified foods expert (21 CFR 114.83). 3. Failure to maintain records identifying initial distribution of acidified products, especially for internet/mail sales (21 CFR 114.100(d)). 4. Failure to prepare and maintain recall procedures, including plans for identifying, collecting, warehousing, controlling products, determining recall effectiveness, and notifying FDA (21 CFR 108.25(e)). 5. Failure to ensure accuracy and maintenance of temperature monitoring devices; an investigator's calibrated thermometer read 8 degrees lower than the firm's device (21 CFR 110.40(f)). 6. Failure to maintain effective measures to exclude pests, with observed rodent excreta pellets throughout retail, warehouse, processing, preparation, ingredient storage, mop, and employee restroom areas (21