WARNING LETTER

September 26, 2019

 WL #1280

Dear Jasmine Contreras:

The United States Food and Drug Administration (FDA) has manually reviewed over 200 of your firm’s listing files from August 2017 to the present and has identified many instances where the listing information failed to comply with the applicable requirements. You have failed to address many of the listing deficiencies detailed in multiple deficiency letters addressed to your company dated August 10, 2017, August 14, 2017, and May 14, 2018. Forty-five days after these FDA letters were sent, emails of data removal notifications were sent to your company and at that time, the listing data associated with these deficiencies were removed from the on-line NDC Directory.  Prompt action must be taken to correct the remaining deficiencies.

Section 510 of the Federal Food, Drug, and Cosmetic Act (“FD&C Act” or the “Act”) outlines the requirements for registration and listing of drug products. Under section 510 of the Act, and 21 CFR Part 207, with some limited exceptions, firms that manufacture[1] drugs in the United States or that are offered for import into the United States must be registered with the FDA.[2] Every person who is required to register must, at the time of initial registration, list all drugs that are manufactured for commercial distribution.[3] Drug listing information also must be updated in June and December of each year.[4] Drug listing updates must include listing information for each drug manufactured for commercial distribution not previously listed with FDA, information regarding drugs for which manufacturing for commercial distribution has been discontinued and any material changes to previously submitted drug listing information.

Although your firm has made some corrections in response to FDA’s deficiency letters, NuCare continues to be in non-compliance with its listing obligations under section 510(j) of the FD&C Act (specifically 510(j)(2) of the Act and various provisions of 21 CFR Part 207. Continued analysis of your firm’s current drug listing files confirms that since FDA first contacted NuCare in August 2017, some of the incorrect listings outlined in the above-mentioned deficiency letters have been addressed and corrected, but many incorrect listings remain unresolved. Also, several drug listings submitted recently by your firm do not meet the listing requirements and include erroneous data.

The chart below details examples of existing violations included in deficiency letters, as well as examples of errors found in more recent drug listing submissions.

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]).

Within seven working days of receipt of this letter please notify this office, in writing, of the specific steps you have and will take to promptly identify and correct each violation, to bring all your products into compliance. Your response also should include an explanation of the specific steps you have and will take to prevent the recurrence of violations. For any steps not completed before submitting this notice, please provide the dates when such steps will be completed.

Your response should include enough information to allow us to evaluate whether the steps you have and will take are enough to correct each violation and prevent the recurrence of violations.  Such responses typically would include, at a minimum, a discussion of:

• How your firm reviewed, or plans to review, all current drug listings to identify those listings that need to be updated;
• How your firm corrected, or plans to correct, the identified errors (e.g., submit corrected SPL files for existing listings, delist NDCs no longer in use by submitting end marketing dates and changing marketing status to complete); and
• The plan or process your firm has implemented, or plans to implement, to prevent the recurrence of the violations.

Your reply should be sent to:

Tasneem Hussain, Pharm. D.

eDRLS Staff

Food and Drug Administration

10903 New Hampshire Avenue

Building 51, Room 2261

Silver Spring, MD 20993-0002

Please be aware that a manual override may be required for certain types of revisions made to an existing drug listing file. 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 1280 on all correspondence.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations of your firm’s registration and product listing obligations or other obligations. It is your firm’s responsibility to ensure compliance with all applicable laws and regulations administered by FDA.

Sincerely,

/S/

Maria Rossana R Cook

cc:       drugs@registrarcorp.com

cc:       Los Angeles District Office

Attn:   FDA Correspondence