Quality CDMO, Inc. – FDA Warning Letter, Jun 16, 2023

The FDA inspected Quality CDMO, Inc. (FEI 3017569510) in Fort Worth, TX, from June 12-16, 2023, and found violations of the Federal Food, Drug, and Cosmetic Act. The firm manufactures prescription 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.

These products are considered "new drugs" under section 201(p)(1) of the FD&C Act because they are not generally recognized as safe and effective (GRASE) for their intended uses, which include treating various dermatological conditions like seborrheic dermatitis, acne, hyperkeratotic conditions, and psoriasis. Since no FDA-approved applications are in effect for these products, their introduction or delivery into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act.

The FDA requires the firm to immediately discontinue marketing all unapproved prescription drugs. Failure to promptly correct these violations may lead to legal actions, including seizure and injunction, and could impact future government contracts or export certificates. The firm must respond in writing within fifteen working days, detailing corrective actions taken or planned, including a timeline if corrections