Ultra Seal Corporation

CLOSEOUT LETTER Ultra Seal Corporation MARCS-CMS 624650 — September 25, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 1317759 Product: Drugs Recipient: Recipient Name Mr. Michael P. Borrello Recipient Title Executive VP of Operations Ultra Seal Corporation 521 Main St, New Paltz , NY 12561 United States Issuing Office: Office of Pharmaceutical Quality Operations United States Secondary Issuing Offices United States Dear Mr. Borrello: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 624650 dated March 14, 2022. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter pertaining to Ultra Seal Corporation FEI 1317759. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. The other two facilities cited in the Warning Letter, ULTRAtab Laboratories Inc. FEI 3003068822 and ULTRAtab Laboratories Inc., FEI 3016117472, will remain in official action indicated (OAI) status (as indicated in the correspondence dated December 8, 2023, and January 7, 2022, respectively). 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/ Craig W. Swanson Deputy Program Division Director OPQO Division I Cc: Ms. Katherine DeHaven Regulatory Affairs Specialist Ultra Seal Corporation 521 Main Street New Paltz, NY 12561 Content current as of: 09/27/2024 Regulated Product(s) Drugs