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WARNING LETTER

American Sales Company Inc MARCS-CMS 582707 — Jul 11, 2019

American Sales Company Inc - 582707 - 07/11/2019


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Drugs

Recipient:
Recipient Name
Mr. James Godwin
American Sales Company Inc

4201 Walden Avenue
Lancaster, NY 14086
United States

Issuing Office:
Center for Drug Evaluation and Research

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

July 11, 2019

WL # 1456

Mr. James Godwin
American Sales Company
4201 Walden Avenue
Lancaster, NY 14086
USA

Dear Mr. Godwin:

The United States Food and Drug Administration (FDA) has reviewed your firm’s listing information provided for diphenhydramine hydrochloride and zinc acetate, NDC 41520-090. Our review revealed that the listing for this product includes inaccurate information. You have failed to address the listing deficiencies detailed in FDA’s letter to your company on March 19, 2019. A data removal notification was also sent to your company on May 3, 2019 and at that time the listing data was removed from the on-line NDC Directory. Prompt action must be taken to correct these deficiencies.

Section 510(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act and 21 CFR Part 207) outlines the requirements for registration and listing of drug products. In the case of diphenhydramine hydrochloride and zinc acetate (NDC 41520-090), the listing must include the name and quantity of each pharmaceutical ingredient listed in the drug.1

A review of the listing for diphenhydramine hydrochloride and zinc acetate, NDC 41520-090, reveals that the active ingredient listed in the electronic listing file does not match the active ingredient found in the labeling. Specifically, the name of the active ingredient included in the labeling is diphenhydramine hydrochloride while the active ingredient name included in the electronic listing file is bromodiphenhydramine hydrochloride.

In addition, FDA regulations require a National Drug Code number for every drug, as well as for each version of the drug.2

A review of the listing for diphenhydramine hydrochloride and zinc acetate, NDC 41520-090, reveals that the product’s listed NDC does not match the NDC appearing on the copy of the label provided in the same listing. Specifically, the NDC included in the copy of the label is 00000-000-00 while the NDC included in the electronic drug listing file is 41520-090. If the NDC is included on a drug carton label, it must match its assigned NDC. Therefore, this deficiency must be corrected to ensure an accurate listing.

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 correct 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 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 1456 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 Rossana R. Cook

______________________________________

1 See 21 CFR Part 207.49(a)(4).

2 See FD&C Act Section 510 (j)(1)(C), 21 C.F.R. 207.33 (d)(i) and 207.49(a)(1).