WARNING LETTER
Netcos Co., Ltd.
MARCS-CMS 565521 —
October 29, 2018
Product:
Drugs
Recipient:
Recipient Name
Bae Tae-Jong
Netcos Co., Ltd.
Netcos Co., Ltd.
3/F Seocho-dong 23- 12 Hyoryeong-ro 60-Gil
Seocho- Gu
Seoul
06721
South Korea
Issuing Office:
Center for Drug Evaluation and Research
United States
WARNING LETTER
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
October 29, 2018
WL # 1326
Bae Tae-Jong
Netcos Co. Ltd.
3/F Seocho-dong 23- 12 Hyoryeong-ro 60-Gil
Seocho- Gu
Seoul, 06721
South Korea
Dear Bae Tae-Jong:
The United States Food and Drug Administration (FDA) has reviewed your firm’s listing information provided for P8 Tone - Up and Brightening Creamex, NDC 71738-0007. Our review revealed that the listing for this product includes inaccurate information. You have failed to address this listing deficiency detailed in FDA’s letter to your company on July 6, 2018, and you have failed to respond to our data removal notification to your company on August 20, 2018.  Prompt action must be taken to correct this deficiency.
Section 510 (j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR Part 207 outline the requirements for registration and listing of drug products. For the product P8 Tone - Up and Brightening Creamex, NDC 71738-0007, the listing must include “the representative sample of labeling for such drug . . .”
[1]
A review of the product P8 Tone-Up and Brightening Creamex, NDC 71738-0007, reveals that the product’s listing submission includes an incorrect or incomplete copy of the label. The image uploaded into the FDA’s Electronic Drug Registration and Listing System (eDRLS) does not appear to be an image of your product’s label. Specifically, the carton label included refers to “DF-2 Doctor Face” “Whitening Wrinkle Recovery” while the listed drug in the electronic listing file refers to “P8 Tone - Up and Brightening Creamex.”
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 listing 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 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 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
edrls@fda.hhs.gov
for further assistance. Include the case identification number of 1326 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 and 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 error(s) and bring the product into compliance.
Sincerely,
/S/
Maria Rossana R. Cook
Director
Office of Program and Regulatory Operations
Office of Compliance
Center for Drug Evaluation and Research
cc:       U. S. Agent-MGK Corporation
mgkeuncorp@gmail.com
[1]
See FD&C Act Section 510(j)(1)(B)(ii), and 21 CFR 207.49(a)(15)(ii)(A).
Content current as of:
11/13/2018
Regulated Product(s)
Drugs