Public Health Service Food and Drug Administration
Center for Drug Evalution and Research Silver Spring, MD 20993-0002
VIA UNITED PARCEL SERVICE
April 19, 2017
WL # «858»
105 Baylis Road
Melville, NY, 11747
Dear Mr. Kornberg:
The United States Food and Drug Administration (FDA), has reviewed your firm’s listing information provided for Exact-Rx Sodium Sulfacetamide and Sulfer 10%/5% Cleanser, NDC 42808-112. Our review revealed that the listing for this product is inaccurate. Prompt action must be taken to correct this deficiency.
Section 510 (j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) outline the requirements for registration and listing of drug products. In the case of Exact-Rx Sodium Sulfacetamide and Sulfer 10%/5% Cleanser, NDC 42808-112, the listing must include, the name and quantity of each active pharmaceutical ingredient listed in the drug.
A review of the listing for Exact-Rx Sodium Sulfacetamide and Sulfer 10%/5% Cleanser, NDC 42808-112, reveals that an active ingredient, Sulfur, is missing from the structured product labeling (SPL) listing information. The active ingredient Ferrous Cation is instead included, which does not match the list of active ingredients included in the product’s labeling. Please also update the incorrect spelling of “Sulfer” to “Sulfur”, found in several places in your listing information. 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)].
This information must be corrected to ensure its accuracy. Information from your firm’s registration and product listing are 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 correct and accurate database in order 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 in order 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 firstname.lastname@example.org for further assistance. Include the case identification number of 858 on all correspondences.
Your reply should be sent to:
Tasneem Hussain, Pharm. D.
Food and Drug Administration
10903 New Hampshire Avenue
Building 51, Room 2261
Silver Spring, MD 20993-0002
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.