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WARNING LETTER

October 17, 2022

RE: WL 2310

Dear Peter Levasseur,

The United States Food and Drug Administration (FDA) has reviewed your firm’s drug listing information provided to FDA’s electronic Drug Registration and Listing System (eDRLS) for your drug product, Lisinopril (NDC 50436-0353). Our review determined that your firm has submitted an incorrect carton label image for the listed product. As such, your firm is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as explained below.

We refer you to FDA’s drug listing deficiency letter notification sent to you on March 15, 2022, describing the deficiency identified below. We also refer you to FDA’s data removal email notification sent to you on April 29, 2022, informing you of a data removal action. As stated in this email, the continued deficiency resulted in your product’s data removal from FDA’s Online NDC Directory.

Section 510(j)(1)(B)(i), and more specifically the listing requirements under 21 CFR 207.49 (a)(15)(ii), state that “all current labeling, except that only one representative container or carton label, need be submitted where differences exist only in the quantity of contents statement or the bar code.” Therefore, the submitted labeling for the listed product needs to appropriately represent the current product. The review of the listing submission for Lisinopril NDC 50436-0353 revealed that the label image uploaded into the FDA’s electronic Drug Registration and Listing System (eDRLS) does not match your product’s label. The active ingredients included in the label image do not accurately reflect the active ingredient included in the electronic listing file (SPL). Specifically, while the electronic listing file refers to Lisinopril, the carton label image included in the same listing submission refers to Pharbetol-Acetaminophen.

Therefore, your firm has not fulfilled its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), which is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, failure to properly list a drug with FDA also renders it misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). The introduction or delivery for introduction into interstate commerce of a misbranded drug product is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Complete, accurate and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Drug registration and listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.

We note that this warning letter only addresses registration and listing issues associated with your product. It is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing recurrence or the occurrence of other violations. We remind you to carefully review all cGMP and labeling requirements for your drug products. It is your responsibility to ensure that your firm complies with all applicable requirements of federal law and FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. In absence of a corrective action, the deficient listing data will not be available for certification under 21 CFR 207.57(b)(2) requirements and will be ultimately inactivated by FDA. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to eDRLS@fda.hhs.gov. 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, “2310” on all correspondence.

Sincerely,
/S/

Carolyn E. Becker, J.D.
Director, Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

CC: Miami District Office
Attn: Arthur.Martin@fda.hhs.gov