Dear Ellen Chang:

The United States Food and Drug Administration (FDA) has reviewed your firm’s listing information provided for (b)(4). Our review revealed that the listing for this product includes inaccurate information. You have failed to address this listing deficiency detailed in FDA’s letter to your company on February 5, 2018, and have failed to respond after our data removal notification to your company on March 22, 2018. Prompt action must be taken to correct this deficiency.

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 (b)(4), the listing must include the name and quantity of each active ingredient listed in the drug.[1]

A review of the listing for (b)(4), 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. Specifically, the labeling includes (b)(4), while the electronic listing (b)(4).

Your firm failed to fulfill its listing obligations under Section 510(j) of the FD&C Act, which is a prohibited act under Section 301(p) (21 U.S.C. 360(j) and 331(p)). In addition, your firm’s failure to fulfill its listing obligations misbrands the product under Section 502(o) of the FD&C Act; introduction or delivery for introduction into interstate commerce of a misbranded product is a prohibited act under Section 301(a) (21 U.S.C. 352(o) and 331(a)).

Information from your firm’s registration and product listing is accessible not only to FDA, but to other interested parties, including consumers. 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.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct this violation. Your response should include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete these corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Please be aware that for your revised SPL submission to be accepted, a manual override may be required for certain types of errors. If you receive a validation error or have any questions regarding the contents of this letter, please contact us at edrls@fda.hhs.gov for further assistance. Include the case identification number of 1285 on all correspondence.

Your reply should be sent to:

Tasneem Hussain, Pharm. D.

eDRLS Team

Food and Drug Administration

Mail Stop HFD-300

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

WO 51, Room 2261

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations found in your firm’s registration and product listing. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the product into compliance.

Sincerely,

/S/

Maria Rosanna R. Cook

Director

Office of Program and Regulatory Operations

Office of Compliance

Center for Drug Evaluation and Research

cc:       Los Angeles District

[1] See FD&C Act § 510(j)(1)(B)(ii) and 21 CFR 207.49(a)(4).