Boiron Freres SAS – FDA Warning Letter, Dec 16, 2011

An FDA inspection of Boiron Freres SAS's juice processing facility in France on December 15-16, 2011, revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). The firm's 100% frozen fruit and vegetable purees are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies included HACCP plans that failed to incorporate control measures to consistently achieve a 5-log reduction of pertinent microorganisms directly in the juice, as required by 21 CFR 120.24(a) and (b). The firm's proposed microbial critical control points, such as surface treatment and freezing, were deemed inadequate. Additionally, the firm failed to validate its HACCP plan's adequacy to control food hazards, specifically the pasteurization or blanching time and temperature parameters for various purees, as required by 21 CFR 120.11(b). The FDA acknowledged the firm's response to the FDA-483 but found it insufficient. Boiron Freres SAS must respond within thirty working days, detailing specific corrective actions and providing supporting documentation. Failure to adequately address these violations may result in refusal of admission for imported products (detention without physical examination) and assessment of re-inspection fees.