Drugs

Repeat Violations at 3 Ultra Seal Facilities

FDA says 2021 inspections at three Ultra Seal facilities in Highland and New Paltz, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/14 Warning Letter lists the violations for each facility as:

ULTRAtab Toc Drive

o failing to establish and follow adequate written procedures for cleaning and maintenance of equipment; and

o failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch had already been distributed.

ULTRAtab Riverside

o failing to establish and follow required laboratory control mechanisms; and

o failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records.

Ultra Seal Corporation

o failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures in-process materials, packaging materials, labeling, and drug products.

The letter says FDA has cited similar CGMP observations at facilities in the company’s network. “These repeated failures at multiple sites demonstrate that your management’s oversight and control over the manufacture of drugs is inadequate,” the letter says.

FDA acknowledged the firm’s commitment to suspend production and testing of drugs at the Toc Drive and Riverside facilities until remediation is completed. FDA also acknowledged Ultra Seal is using a consultant to audit its operation and assist in meeting FDA requirements.

Ultra Seal was told to correct violations promptly and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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