FDA WARNING_LETTER - Clements Foods Co - February 13, 2015

On February 4-13, 2015, an FDA inspection of Clements Foods Company in Oklahoma City, OK, revealed serious violations of acidified food regulations (21 CFR Part 108 and Part 114). The firm manufactures various acidified foods. The FDA-483 issued at the inspection's conclusion listed deviations, and the firm's February 13, 2015, response was deemed inadequate.

The identified violations include: 1. Failure to file scheduled processes with FDA for (b)(4) Syrup and (b)(4) Syrup, as required by 21 CFR 108.25(c)(2). The response lacked a timeframe for submission. 2. Failure to have scheduled processes for (b)(4) Syrup and (b)(4) Syrup established or evaluated by a qualified process authority, violating 21 CFR 114.83. The response provided no details on when this would occur. 3. Failure to process acidified food in conformity with the scheduled process, as required by 21 CFR 108.25(c)(3)(i). Specifically, (b)(4) acid was added to (b)(4) Syrup batches, despite not being listed as the acidifying agent in the filed scheduled process. The response stated cessation of this practice but lacked a plan for future pH control. 4.