WARNING LETTER
Davati Medical Supply LLC
MARCS-CMS 615530 —
June 25, 2021
Product:
Biologics
Recipient:
Recipient Name
Herman Cardenas
Davati Medical Supply LLC
3121 Eagles Nest St., Suite 120
Round Rock
,
TX
78665
United States
contact@davatimedical.com
Issuing Office:
Center for Biologics Evaluation and Research
United States
CBER 21-02
WARNING LETTER
Date: June 25, 2021
RE: Unapproved and Misbranded Product Related to Influenza Virus
This is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at www.davatimedical.com, on June 22, 2021. Your website directs consumers to contact you to purchase FLUZALP® QUADRIVALENT, Influenza Vaccine, which you represent is manufactured by Anzalp Pharmasolutions Pvt. Ltd. The FDA has observed that you offer this influenza vaccine product for sale in the United States and that the product is intended to mitigate, prevent, treat, diagnose, or cure Influenza Virus, commonly referred to as “the Flu”, in people.
Based on our review, this product is an unapproved new drug under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355. Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
Your product is also an unlicensed biological product under section 351 of the Public Health Service Act (PHS Act), 42 U.S.C. § 262. In order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect under the PHS Act. 42 U.S.C. § 262(a). Such licenses are issued only after a demonstration that the product is safe, pure, and potent. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations. 21 U.S.C. § 355(i); 42 U.S.C. § 262(a)(3); 21 CFR Part 312. Your product is not the subject of an approved biologics license application (BLA) nor is there an IND in effect for your product.
FDA is taking urgent measures to protect consumers from certain products that, without licensure, approval, or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure Influenza Virus in people. As described in this letter, you offer for sale a product that is intended to mitigate, prevent, treat, diagnose, or cure Influenza Virus in people. We request that you take immediate action to cease the sale of any unlicensed, unapproved, and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of Influenza Virus.
Some examples of the claims on your website that establish the intended use of your product and misleadingly represent it as safe and/or effective for the prevention of Influenza Virus include:
• “FLUZALP™ Quadrivalent is an inactivated Influenza vaccine indicated for active immunization against Influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUZALP QUADRIVALENT is approved for use in persons 4 years of age and older.”
• “The quadruple strain formula provides protection for up to 6 months*. The product’s dosage form is injection, suspension and is administered via intramuscular form.”
• “Each batch of these vaccines is then tested by FDA for Quantity, Quality and Efficacy before being release [sic] into the market.”
You should take immediate action to correct any violations of the FD&C Act, the PHS Act, and FDA’s implementing regulations. This letter is not meant to be an all-inclusive list of violations that exist in connection with your product or operations. It is your responsibility to ensure that you and your products fully comply with the law.
We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your product as safe and effective for an Influenza Virus-related use for which it has not been licensed by FDA and that you do not make claims that misbrand the product in violation of the FD&C Act.
Within 48 hours, please send an email to CBERDCMRecommendations@fda.hhs.gov
describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction.
This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which your product is exported to the United States that FDA considers your product referenced above to be an unapproved and misbranded product that cannot be legally sold to consumers in the United States.
Please direct any inquiries to FDA at CBERDCMRecommendations@fda.hhs.gov.
Sincerely,
/S/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Content current as of:
07/06/2021
Regulated Product(s)
Biologics