FDA WARNING_LETTER - SDP Marketing and Distribution, Inc. - December 08, 2014

On January 9, 2015, the FDA issued a Warning Letter to SDP Marketing and Distribution, Inc. following an inspection from December 2-8, 2014. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).

The firm's dried shrimp and flavored fruit and nut snacks were deemed adulterated due to insanitary conditions. Specific violations included: 1. **Lack of a HACCP plan for Dried Whole Shrimp and Dried Jumbo Shrimp** to control undeclared sulfites. The firm's submitted HACCP document was inadequate, lacking clear CCPs, critical limits, monitoring, corrective actions, and verification procedures. No evidence of relabeling or employee training on new HACCP procedures was provided. 2. **Failure to maintain sanitation control records** for water safety, food contact surface cleanliness, cross-contamination prevention, handwashing/toilet facilities, food protection from adulteration, toxic compound control, employee health, and pest exclusion. The firm's response lacked evidence of current record maintenance or employee training. 3. **Use of non-corrosion-resistant and improperly designed food contact surfaces.** A cement-style mixer used for snack products had missing paint, rust, unsecured bolts, and an uncleanable interior, making it