The FDA Issues Warning Letters to Two Food Manufacturers for Repeated Violation of Good Manufacturing Practices (GMP)

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    The FDA Issues Warning Letters to Two Food Manufacturers for Repeated Violation of Good Manufacturing Practice (GMP)
    The FDA Issues Warning Letters to Two Food Manufacturers for Repeated Violation of Good Manufacturing Practice (GMP)

    The FDA Issues Warning Letters to Two Food Manufacturers for Repeated Violation of Good Manufacturing Practices (GMP)

    The U.S. Food and Drug Administration (FDA) is responsible for maintaining the integrity of human and animal food and drug products across the United States. One aspect of this includes the regular inspection of food manufacturers and the like. When a food handler or producer is found to have violated food safety practices, specifically outlined in the Good Manufacturing Practices (GMP) Resources, it is the FDA’s job to hold them accountable. Typically, warning letters are only issued after a company has repeatedly failed to comply with safety guidelines, as well as after it has been given adequate time to implement and prove its reform (sometimes being months, even years). Oftentimes, when the FDA issues a warning letter to a company it is not made visible to the public. Additionally, the company is given 15 days to respond and outline its plan of compliance with the provided guidelines.

    This month, the FDA made public two warning letters to two California based food companies, whose prior warnings date back to as early as June, 2020.

    The FDA issued a warning letter to OCM Group USA Inc., located in City of Industry, CA, pertaining to food safety violations discovered during an inspection of its facility in May, 2020. OCM Group USA Inc., responded to the initial warning on June 24, 2020 asking for a period of two months to collect the necessary paperwork and to develop a Food Supplier Verification Program (FSVP). The FDA issued its most recent warning on October 16, 2020, restating the safety concerns and the company’s failure to respond within the requested two months.The warning states that OCM Group USA is “not in compliance with the requirements of 21 CFR part 1 subpart L for the food products [it] import[s]” including its Crushed Chili and Sesame product imports. Additionally, the company admitted to still not having established a Food Supplier Verification Program (FSVP), a requirement intended to ensure that imported goods meet USA standards. The warning letter gives OCM Group USA Inc. 15 business days to respond. To read the full warning letter click here.

    The FDA also issued a warning letter to Ramar International Corporation, located in CA, due to several violations of food safety policy which were discovered after an investigation which took place between May and June, 2020. Despite the company’s prompt response to the FDA with a plan in regards to these concerns, recent investigation indicates this response was inadequate. The most recent warning letter, issued on October 13, 2020, states that the sanitization methods, employee handling procedures, and facility conditions remain inadequate to avoid recurrent contamination of Listeria monocytogenes. Ramar International Corporation has been given 15 business days to respond and outline its plan of compliance with the provided guidelines. To read the full warning letter click here.

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ramar-international-corporation-608782-10132020
    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ocm-group-usa-inc-609106-10162020

    zhttps://ispe.org/initiatives/regulatory-resources/gmp

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