FDA WARNING_LETTER - JLM Manufacturing LLC - April 10, 2013

The FDA issued a Warning Letter to JLM Manufacturing, LLC. following an inspection of their seafood processing operations, specifically Tuna Salad Sandwiches, conducted in March and April 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, rendering their Tuna Salad Sandwiches adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The primary violations include: 1) Failure to have and implement a written HACCP plan to control reasonably likely food safety hazards, as required by 21 CFR 123.6(b). This involved a failure to implement monitoring, verification, and recordkeeping procedures for hazards like Histamine, Clostridium botulinum, food allergens, and additives. 2) Failure to maintain adequate sanitation control records documenting monitoring and corrections, as mandated by 21 CFR 123.11(c). This deficiency covered critical areas such as water safety, cross-contamination prevention, hand washing facilities, food protection, chemical handling, employee health, and pest control. The firm's May 3, 2013, response to the FDA 483 observations was deemed inadequate due to a lack of documentation or evidence of implemented corrections. JLM Manufacturing, LLC. is required to respond within fifteen working days, detailing specific corrective actions with supporting documentation. Failure to promptly correct these violations may result in further regulatory action, including product seizure and/or an injunction preventing the firm from operating. The company is responsible for ensuring full compliance with the Act and 21 CFR Part 123.