FDA Cites GC America, Inc. in May 14, 2026 Warning Letter — CGMP/Finished Pharmaceuticals/Adulterated

FDA Warning Letter — Violations FDA cited at GC America, Inc.

WARNING LETTER GC America, Inc. MARCS-CMS 727602 — May 14, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Return Receipt Requested Reference #: 320-26-76 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Joseph T. Talanges Recipient Title President & Chief Operating Officer GC America, Inc. 3737 West 127th Street Alsip , IL 60803 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States May 14, 2026 WARNING LETTER Dear Mr. Talanges: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, GC America, Inc., FEI 1410097, at 3737 West 127th Street, Alsip, Illinois, from November 3 to 7, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). We reviewed your November 21, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigator observed specific violations including, but not limited to, the following. 1. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm manufactures OTC drug products, including those for (b)(4) . Your firm failed to ensure components were suitable for use in manufacturing your drug products. (b)(4) Used as a Component in Drug Products You did not adequately demonstrate your (b)(4) , at a minimum, meets specifications in the United States Pharmacopeia (USP) (b)(4) monograph. For example, your (b)(4) system records show that you only performed (b)(4) testing. However, the USP monograph requires additional testing for chemical purity and microbial quality. We also noted you failed to establish a procedure describing (b)(4) sampling requirements and acceptance criteria. According to your management, you manufactured approximately (b)(4) finished drug batches with inadequately tested (b)(4) from 2023 through 2025. Products Containing Ingredients at Risk for (b)(4) Contamination You also state in your correspondence to the agency that you do not conduct identity testing on each shipment of each lot of your incoming components at high risk of (b)(4) contamination before using them to manufacture your drug products. This includes, but is not limited to, testing (b)(4) to determine its appropriate identity prior to use in manufacturing your drug products. Identity testing for (b)(4) and certain other high-risk drug components includes a USP limit test to ensure the component meets the relevant safety limits for (b)(4) levels. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products. The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4). In your response, you acknowledge you do not perform all testing of (b)(4) per USP, and you commit to sending a sample of your (b)(4) to a third-party testing laboratory. You also commit to conducting a risk assessment of your deficient (b)(4) testing on drug products released from 2023 to 2025 and to establishing a (b)(4) testing SOP. Your response is inadequate. You do not provide a detailed procedure explaining