Maria Distribution Sarl – FDA Warning Letter, Jan 10, 2014

The FDA inspected Maria Distribution Sarl in Dakar, Senegal, on January 9-10, 2014, and found serious deviations from the Emergency Permit Control (21 CFR 108) and Acidified Foods (21 CFR 114) regulations for their acidified food products intended for U.S. export. The firm's subsequent corrective action responses were deemed inadequate. Key violations include the failure to file scheduled processes for their Pepper Sauce (Habanero) in 450g and 250g glass jars, as required by 21 CFR 108.25(c)(2), with previous filings needing re-submission. The firm also failed to exercise sufficient control and frequent testing to ensure finished equilibrium pH values are not higher than 4.6, as mandated by 21 CFR 114.80(a)(2), specifically by not testing pH after cooling. Additionally, the firm failed to mark each container with an identifying code specifying the establishment and product, violating 21 CFR 114.80(b). These deficiencies render the products adulterated under Section 402(a)(4) of the Act. Maria Distribution Sarl must respond within 15 working days, outlining specific corrective steps with supporting documentation. Failure to adequately address these issues may lead to refusal of admission for their products under Section 801(a), detention without physical examination (DWPE) via Import Alert #99-38, and assessment of reinspection-related fees.