Corporate Essentials LLC

Warning LetterOpen

Mr. Judson Kleinman Owner and CEO Corporate Essentials LLC 2 Cranberry Road, Ste. A2 Parsippany , NJ 07054 United StatesFEI 3003353909Issued Jan 5, 2023Division of Northeast Imports

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Violations1

Issue DateJan 5, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: Corporate Essentials LLC
Location: Mr. Judson Kleinman Owner and CEO Corporate Essentials LLC 2 Cranberry Road, Ste. A2 Parsippany , NJ 07054 United States
FEI Number: 3003353909
Country: United States
Issue Date: January 05, 2023
Issuing Office: Division of Northeast Imports
Product Type: Other
Status: Open

Summary

Corporate Essentials LLC, a food importer based in New Jersey, failed to comply with the Foreign Supplier Verification Program (FSVP) requirements for imported food products, specifically liquid chocolate drinks. The company did not develop, maintain, or follow any FSVP plan as required by section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L, despite multiple FDA inspections conducted in 2018, 2020, and most recently from June to September 2022. The FDA did not receive a response to the Form FDA 483a observations issued on September 22, 2022, compounding the compliance violations.

Corporate Essentials LLC FDA Warning Letter, January 5, 2023