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FDA's CDER Warns California Company for Inaccurate Listing

Posted 06 November 2018 | By Zachary Brennan 

FDA's CDER Warns California Company for Inaccurate Listing

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released a warning letter sent to Cerritos, CA-based United Exchange Corp. for including inaccurate information in a listing of an unidentified product.

The listing deficiency, first detailed by FDA to the company in a 5 February letter, was still uncorrected even after FDA sent a data removal notification to the company on 22 March.

“Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 207 outline the requirements for registration and listing of drug products. For the product [redacted], the listing must include the name and quantity of each active ingredient listed in the drug.” 

A review of the listing “reveals that the active ingredients listed in the electronic listing file (SPL) do not match the active ingredients found in the labeling provided with the SPL,” FDA said.

Information from the firm’s registration and product listing is accessible not only to FDA, but to consumers too, FDA said.

“Your product’s listing information has been removed from the FDA’s Online NDC Directory and will not be available for public viewing until the corrections are made. This is an effort to maintain a complete and accurate database to protect and promote the public health,” the letter noted.

FDA requests that within 15 days of receiving the letter, dated 29 October, the company notify the agency of steps to correct the violation.

Warning Letter
 

Categories: Regulatory News

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