FDA WARNING_LETTER - Best of Texas, Inc. - May 24, 2011

The FDA conducted inspections of Best of Texas, Inc. from February 15-22, 2011, and May 19-24, 2011, revealing serious violations of regulations for acidified foods (21 CFR Part 108 and Part 114). Consequently, the firm's acidified food products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Significant violations included the failure to file scheduled processes for multiple acidified food products, such as Hot Pepper Relish and Baby Beet Pickles, as required by 21 CFR 108.25(c)(2). Additionally, the firm failed to maintain adequate processing and production records, including critical pH measurements and other factors like hot water bath temperature and time, for numerous lots, violating 21 CFR 114.100(b). Lastly, the company did not consistently maintain records identifying the initial distribution of specific acidified product lots, as mandated by 21 CFR 114.100(d). The FDA requires prompt corrective actions, with a written response due within fifteen working days detailing steps taken to correct deviations, prevent recurrence, and provide supporting documentation. Failure to comply may result in further regulatory actions, including emergency permit control, injunction, or seizure.