FDA WARNING_LETTER - First Commercial Kitchen, L.L.C. - February 04, 2011

The FDA conducted an inspection of First Commercial Kitchen, L.L.C. in Waipahu, Hawaii, from December 28, 2010, to February 4, 2011. The inspection revealed significant deviations from Acidified Food regulations (21 CFR Part 108 and Part 114), rendering products adulterated under Section 402(a)(4) of the Act.

Violations included: 1. **Failure to conform to scheduled process (21 CFR 108.25(c)(3)(i)):** Black Bean Sauce's equilibrium pH was found to be as high as 4.8, exceeding the filed scheduled process maximum of (b)(4). 2. **Failure to file scheduled processes (21 CFR 108.25(c)(2)):** No scheduled processes were filed for Arturo’s Hot Flavors of Hawaii Moloka’i Hot Sauce and India Café Creamy Tikka Masala Sauce. 3. **Inadequate pH control monitoring (21 CFR 114.80(a)(2)):** The firm was not monitoring the final equilibrium pH for any processed acidified food products, including Moloka’i Hot Sauce, Tikka Masala Sauce, and Black Bean Sauces, to ensure values were not higher than 4.6. 4. **Failure to maintain processing records