FDA WARNING_LETTER - Corporate Essentials LLC - September 22, 2022

From June 29 to September 22, 2022, the FDA conducted an FSVP inspection of Corporate Essentials LLC, following previous inspections on August 21, 2018, and February 11, 2020. The inspection aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandate risk-based activities for importers to verify imported food meets U.S. safety standards.

The inspection revealed significant violations, specifically that Corporate Essentials LLC failed to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). This non-compliance also violates section 805 of the FD&C Act. An FDA Form 483a FSVP Observations was issued on September 22, 2022, to which no response has been received.

The FDA warns that failure to adequately address these violations may lead to further action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert # 99-41. Additionally, importing food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act.

Corporate Essentials LLC must respond in writing