WARNING LETTER
Lydia Co. Ltd.
MARCS-CMS 659646 —
June 26, 2023
Reference #:
WL - 2575
Product:
Drugs
Recipient:
Recipient Name
Ho Dong Yang
Lydia Co. Ltd.
102 Dongguk-ro
Ilsandong-gu
Goyang-si
Gyeonggi-do
10325
South Korea
onbix@naver.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
June 26, 2023
RE: WL - 2575
Dear Ho Dong Yang:
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 products, Hot Pap Cataplasma (NDC 72988-0007), Amuldy Sports Gel (NDC 72988-0023), Zenol Cool (NDC 72988-0026), Antiphlamine (NDC 72988-0028), Mentholatum (NDC 72988-0031), New Hanbang Col Cap (NDC 72988- 0032), Nocold-S (NDC 72988-0033), and Albothyl (NDC 72988-0035). Our review determined that your firm has submitted contradictory information between the labeling and the electronic listing files. As such, your firm is in violation of the Federal Food, Drug, and in Cosmetic Act (FD&C Act) as explained below.
We refer you to FDA’s drug listing deficiency letter notification dated March 17, 2023, describing the observed listing deficiencies in the information you submitted. We also refer you to FDA’s data removal email notification sent on May 1, 2023, informing you of a data removal action. As stated in this email, the continued deficiencies resulted in your products’ data removal from FDA’s Online NDC Directory.
Section 510(j)(1) 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. In the case of your products’, Hot Pap Cataplasma (NDC 72988-0007), Amuldy Sports Gel (NDC 72988-0023), Zenol Cool (NDC 72988-0026), Antiphlamine (NDC 72988-0028), Mentholatum (NDC 72988-0031), New Hanbang Col Cap (NDC 72988-0032), Nocold-S (NDC 72988-0033), and Albothyl (NDC 72988-0035), there are various discrepancies between the labeling and the electronic listing files. The following table outlines the specific errors found in each listing submission for products.
Product name
as submitted
in the listing
file
Product
NDC
Error(s) found
Legal citation(s)
Hot Pap
Cataplasma
72988-
0007
1. The list of active ingredients does
not match between the labeling and
the electronic listing file. Specifically,
while the labeling includes methyl
salicylate and vanillyl nonylamide, the
electronic listing file only includes the
methyl salicylate.
Under 21 CFR
207.49(a)(4), each
registrant must provide
the name and quantity of each active
pharmaceutical
ingredient in the listed
drug.
2. There is incomplete package
quantity information under the
packaging section of the electronic
listing file. Specifically, while the
labeling indicates that the total
quantity supplied is 5 sheets, with
each sheet weighing 13.4 g, the
packaging section of the electronic
listing file, only includes package
code of (1) which corresponds to one
sheet or a total of 13.4 g. Another
package code corresponding to the
quantity of 5 sheets is not included.
Under 21 CFR 207.49(a)(2), each registrant must provide the package type and volume information corresponding to the package code segment of the NDC.
Amuldy Sports Gel
72988-0023
1. The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the labeling menthol, methyl salicylate, camphor and salicylic acid,
the electronic listing file only includes menthol.
Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of each active pharmaceutical
ingredient in the listed drug.
Zenol Cool
72988-
0026
1. The list of active ingredients does not match between the labeling and the electronic listing file. Specifically, while the labeling includes menthol, and methyl salicylate, the electronic listing file only includes methyl salicylate.
Under 21 CFR 207.49(a)(4), each
registrant must provide
the name and quantity of
each active pharmaceutical ingredient in the listed drug.
Antiphlamine
72988-
0028
1. There is a mismatched dosage
form between the labeling and the
electronic listing file. Specifically,
While the labeling includes the
dosage form as lotion, the electronic
listing file includes the dosage form
as ointment.
Under 21 CFR
207.49(a)(6), each
registrant must provide
the dosage form for each
listed drug.
Mentholatum,
72988-
0031
1. The strength of the active
ingredients as expressed in the
electronic listing file is misleading.
Specifically, while the strength of the
active ingredients, DL menthol and
methyl salicylate in the labeling is
expressed in milligrams/ gram, the
strength of these active ingredients in
the electronic listing file is expressed
in milligrams/ milliliter.
Under 21 CFR
207.49(a)(4), each
registrant must provide
the name and the
quantity of each active
pharmaceutical
ingredient in the listed
drug.
New Hanbang
Col Cap
72988-
0032
1.The list of active ingredients does
not match between the labeling and
the electronic listing file. Specifically,
while the Drug Facts section of the
labeling states, acetaminophen,
caffeine anhydrous, chlorpheniramine
maleate, and tipepidine hibenzate,
the electronic listing file includes only
acetaminophen and caffeine.
Under 21 CFR
207.49(a)(4), each
registrant must provide
the name and quantity of
each active
pharmaceutical
ingredient in the listed
drug.
Nocold-S
72988-
0033
1. The list of active ingredients does
not match between the labeling and
the electronic listing file. Specifically,
while the active ingredients included
in the product’s labeling appear to be
acetaminophen and
chlorpheniramine, the nonproprietary
name field in the electronic listing file,
includes the active ingredients as
acetaminophen and caffeine.
Under 21 CFR
207.49(a)(4), each
registrant must provide
the name and quantity of
each active
pharmaceutical
ingredient in the listed
drug.
2. There is mismatched strength of t
he active ingredient,
chlorpheniramine, between the labeling and the electronic listing file. Specifically, while the strength in the
labeling is 2.5 mg in 20 ml, the strength of chlorpheniramine in the
electronic listing file is included as 200 mg in 20 ml.
Under 21 CFR
207.49(a)(4), each
registrant must provide
the name and quantity of
each active
pharmaceutical ingredient in the listed drug.
Albothyl
72988-
0035
1. There is mismatched or misleading strength of active ingredient, policresulen, between the labeling and the electronic listing file. Specifically, while the strength, included in the labeling is 720 mg/g, the strength for policresulen in the electronic listing file is 720 mg in 1 ml.
Under 21 CFR 207.49(a)(4), each registrant must provide the name and quantity of
each active pharmaceutical ingredient in the listed drug.
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 products. It is not intended to be an all-inclusive statement of violations that may exist in connection with your products. Your firm should investigate and determine the causes of any violations and take prompt actions to correct the violations and bring the products into compliance.
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, 2575 on all correspondence.
Sincerely,
/S/
Tina Smith
CC: FDA District Office
CC: onbixus@gmail.com
Attn: U.S. Agent
Content current as of:
07/04/2023
Regulated Product(s)
Drugs