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  5. Quality CDMO, Inc. - 665961 - 09/11/2024
  1. Warning Letters

WARNING LETTER

Quality CDMO, Inc. MARCS-CMS 665961 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Anin Shakiba
Recipient Title
President
Quality CDMO, Inc.

5000 South Freeway, Suite 106
Fort Worth, TX 76115
United States

a.shakiba@qcdmo.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

WARNING LETTER

September 11, 2024

RE: CMS 665961

Dear Mr. Shakiba:

The U.S. Food and Drug Administration inspected your drug manufacturing facility, Quality CDMO, Inc. FEI 3017569510, at 5000 South Freeway, Suite 106, Fort Worth, TX, from June 12 – 16, 2023. Based on our inspection and subsequent review of your firm’s website, we found violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

Your firm manufactures many drug products, including Sodium Sulfacetamide 10% Wash, Sodium Sulfacetamide 10% and Sulfur 5% Cleanser, Selenium Sulfide 2.25% Shampoo, Urea 40% Cream, and Salicylic Acid 5.9% Topical Cream as prescription drug products. Your firm is responsible for introducing or delivering for introduction into interstate commerce products that are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introducing, or delivering unapproved new drug products for introduction into interstate commerce is prohibited under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C., 331(d) and 355(a). These violations are described in more detail below.

Unapproved New Drug Violations

Sodium Sulfacetamide 10% Wash, Sodium Sulfacetamide 10% and Sulfur 5% Cleanser, Selenium Sulfide 2.25% Shampoo, Urea 40% Cream, and Salicylic Acid 5.9% Topical Cream are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.

We reviewed labeling collected at your firm and labeling submitted to the electronic Drug Registration and Listing System for the products listed above that provide evidence of the intended uses (as defined in 21 CFR 201.128) of your products, which include, but may not be limited to, the following:

Sodium Sulfacetamide 10% Wash
• Indicated for “topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.”

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser
• Indicated for use in “the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.”

Selenium Sulfide 2.25% Shampoo
• Indicated for the treatment of “seborrheic dermatitis of the scalp, dandruff and tinea versicolor.”

Urea 40% Cream
• Indicated for “the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.”

Salicylic Acid 5.9% topical cream
• Indicated as a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis.

Your products, Sodium Sulfacetamide 10% Wash, Sodium Sulfacetamide 10% and Sulfur 5% Cleanser, Selenium Sulfide 2.25% Shampoo, Urea 40% Cream, and Salicylic Acid 5.9% Topical Cream are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, are considered new drugs as defined in section 201(p)(1) of the FD&C Act. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Because no FDA-approved applications are in effect for your products pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, the introduction or delivery for introduction of these products into interstate commerce violates section 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal actions without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. You should discontinue marketing all of the unapproved prescription drugs manufactured at your facility immediately. Additionally, FDA may withhold approval of requests for export certificates or approval of pending new drug applications listing your facility as a manufacturer until the above violations are corrected. A reinspection may be necessary to verify corrective actions have been completed.

FDA requests that you contact CDER's Drug Shortages Staff immediately at drugshortages@fda.hhs.gov so that we can work with you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture, as required under 21 U.S.C.§ 356c(a), and to allow FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who use your products.

Please notify this office in writing within fifteen (15) working days of receiving this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If the corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the timeframe within which the corrections will be completed. Please include copies of any documentation demonstrating that corrections have been made. If you no longer manufacture or market the above-mentioned products, or any other unapproved new drug products that you have listed in the FDA electronic Drug Registration and Listing System (eDRLS), your response should indicate this, including the reasons that, and the date on which, you ceased production. Also, please indicate your progress in updating the drug listing eDRLS files in accordance with 21 CFR 207.30(a)(2). 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 within 15 working days.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 665961” in the subject line of the email.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

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