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CLOSEOUT LETTER

Ultra Seal Corporation MARCS-CMS 624650 —

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

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