FDA WARNING_LETTER - Cal Valls - January 27, 2012

The FDA inspected Cal Valls' acidified foods facility in Vilanova de Bellpuig, Spain, on January 26-27, 2012, identifying serious deviations from Acidified Foods (21 CFR Part 114) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. The inspection resulted in an FDA-483. While the firm's February 13, 2012, response adequately addressed CGMP deviations, concerns remain regarding acidified foods.

The "BIO Asparagus" and "Piquillo Whole Peppers" products were found to be misbranded under Section 403 of the Act. Specifically, labels did not bear the correct name and place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5(c), as these products are processed by an unregistered contract manufacturer. Cal Valls was using its FCE and SID numbers for these products, despite not being the actual processor. Additionally, the labels were misbranded under Section 403(f) because not all required information was declared in both the foreign language and English, as mandated by 21 CFR 101.15(c).

For olive products, the FDA recommended submitting revised scheduled process filings to determine if they are fermented products, potentially excluded from acidified foods regulations. The firm must respond in writing within fifteen working days,