FDA WARNING_LETTER - Bedessee Imports, Inc - May 16, 2017

On December 1, 2017, the FDA issued a Warning Letter to Bedessee Imports, Inc. following an inspection from May 2-16, 2017, at their Brooklyn, NY facility. The inspection revealed serious violations of seafood HACCP (21 CFR Part 123), juice HACCP (21 CFR Part 120), and Current Good Manufacturing Practice (CGMP) for foods (21 CFR Part 110).

Specifically, the company failed to implement affirmative steps for imported seafood (Ready-to-eat Sardines and Mackerel), rendering them adulterated under 21 U.S.C. § 342(a)(4). Similarly, they lacked written procedures, product specifications, and affirmative steps for imported juice (Fruit of Life Coconut Water Diabetic Choice), also deeming it adulterated.

CGMP violations included inadequate pest protection (torn strips, pigeons in loading bay), insufficient space for equipment and material storage (pallets against walls and in aisles), and improper rubbish disposal (empty boxes near open door attracting pests).

Furthermore, several Fruit of Life Coconut Water products were deemed unapproved new drugs and misbranded drugs due to website claims (e.g., "Lower your risk of heart attacks & high blood pressure," "preventing cancer," "treat Alzheimer’s disease"). These products are not recognized as safe and effective for these uses and lack adequate directions for use