FDA WARNING_LETTER - Ultra Seal Corporation - September 14, 2021

The FDA inspected ULTRAtab Laboratories Inc. (Toc Drive and Riverside facilities) and Ultra Seal Corporation between August and November 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering drug products adulterated under 21 U.S.C. 351(a)(2)(B). Violations at ULTRAtab Toc Drive included inadequate cleaning procedures (a repeat observation) and failure to thoroughly investigate out-of-specification (OOS) results. ULTRAtab Riverside also failed to adequately investigate OOS results, lacked established laboratory control mechanisms (e.g., unvalidated test methods, unreliable Excel workbooks), and failed to exercise appropriate controls over computer systems, including audit trails. Ultra Seal Corporation, overseeing both facilities, failed to establish an adequate Quality Control Unit with proper authority and oversight, leading to drug product release based on unvalidated/unverified methods and inadequate stability testing. These repeat observations across multiple sites demonstrate inadequate management oversight and systemic quality system failures, particularly concerning data integrity. The firm has suspended production and testing at the affected facilities and hired consultants. The FDA requires comprehensive, independent retrospective assessments, remediation plans, revised SOPs, and a response within 15 working days, warning of potential regulatory actions like seizure, injunction, and withholding of export certificates or application approvals.