Kalchem International, Inc.

CLOSEOUT LETTER Kalchem International, Inc. MARCS-CMS 607098 — March 20, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 1000149906 Product: Drugs Recipient: Recipient Name Ms. Kalyn R. Tabor Recipient Title President, Owner Kalchem International, Inc. 224 S. Main St Ste B Lindsay , OK 73052 United States Issuing Office: Office of Pharmaceutical Quality Operations, Division II United States Secondary Issuing Offices United States Dear Ms. Tabor: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Case # 607098 dated August 27, 2020. Based on our evaluation, it appears that you have addressed the violations and deviations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations and deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Chhaya Shetty Compliance Officer Division of Drug Quality I Content current as of: 03/24/2025 Regulated Product(s) Drugs