Drugs

CGMP Issues at Seaway Pharma

A 5/18-6/18 FDA inspection at the Seaway Pharma drug manufacturing facility in Massena, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/1 Warning Letter says the specific violations were:

failure to establish adequate written responsibilities and procedures applicable to the quality control unit;
failure to conduct at least one test to verify the identity of each component of a drug product; and
failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess.

The letter reminds Seaway that it is responsible for the quality of the drugs it produces as a contract facility, regardless of agreements in place with product owners. It acknowledges a previous change of ownership, but says the facility and multiple responsible officers remained the same. “Repeated failures demonstrated during subsequent inspections conducted in 9/2021, 9/2023, and 6/2025 indicate that executive management oversight and control over the manufacture of drugs are inadequate,” FDA says.

The letter says that significant findings in the letter demonstrate that Seaway does not operate an effective quality system under CGMP. FDA recommends that the company retain a qualified consultant to perform a comprehensive system audit of its entire operation and assist it in meeting CGMP compliance.

Seaway was told to correct the violations promptly and to respond with a list of specific steps it has taken to address 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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