Legacy Pharmaceutical Packaging LLC

CLOSEOUT LETTER Legacy Pharmaceutical Packaging LLC MARCS-CMS 633735 — May 10, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3004453700 Product: Drugs Recipient: Recipient Name Mr. Bradley M. Rayner Recipient Title President Legacy Pharmaceutical Packaging LLC 13333 Lakefront Dr. Earth City , MO 63045 United States Issuing Office: Division of Pharmaceutical Quality Operations III United States Secondary Issuing Offices United States Dear Mr. Rayner: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #633735 dated October 3, 2022. Based on our evaluation, it appears that you have addressed the violations 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 be observed during a subsequent inspection or through other means. Sincerely, /S/ Frank Wackes Compliance Officer Division of Drug Quality II Content current as of: 05/30/2024 Regulated Product(s) Drugs