- Delivery Method:
- VIA UNITED PARCEL SERVICE
Recipient NameRich Mangini
- RPK Pharmaceuticals Inc.
3281 Whipple Rd
Union City, CA 94587
- Issuing Office:
- Center for Drug Evaluation and Research
March 26, 2021
WL # 1663
Dear Rich Mangini:
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, “clotrimazole and betamethasone dipropionate cream” (NDC 53002-9740). Our review determined that your firm has submitted a label for this drug that does not match the name of the listed drug. As such, your firm is in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as explained below.
We note that FDA previously sent your firm two letters, one on April 13, 2020 notifying you of listing deficiencies and a subsequent removal notification on May 28, 2020. As stated in the removal notification letter, the continued deficiency resulted in your product’s removal from FDA’s Online NDC Directory.
Section 510(j) of the FD&C Act and 21 CFR 207 outline drug registration and listing requirements. Under section 510(j)(1)(B)(ii), 21 U.S.C. 360(j)(1)(B)(ii), a firm must include in the listing, among other requirements, the “label and package insert for such [listed] drug.” However, the label you provided to FDA does not match the drug you listed with FDA. Specifically, the label image you provided to FDA states “triamcinolone 0.1 % ointment,” whereas the product name included in the drug listing submission is “clotrimazole and betamethasone dipropionate cream.” These are different drug products with different active ingredients.
Therefore, your firm has not fulfilled 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, failure to properly list a drug with FDA also renders it misbranded under section 502(o) of the FD&C Act, and in violation of section 301(a) of the FD&C Act, 21 U.S.C. 352(o) and 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including 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. 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 firstname.lastname@example.org. 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 email@example.com for further assistance. Include the case identification number of 1663, on all correspondence.
Carolyn E. Becker, J.D.
Director, Office of Unapproved Drugs & Labeling Compliance
Center for Drug Evaluation and Research
Office of Compliance
U.S. Food and Drug Administration