North Country Leader

There was one company in a city associated with St. Lawrence County that received FDA citations as a result of one inspection conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous year.

The citations in the county include:

• The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices and written procedures required by current good manufacturing practice regulations.
• Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.

The company cited was involved in the Drugs sector.

The company cited had to take regulatory and/or administrative actions.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
Seaway Pharma, Inc.	Drugs	09/21/2023	Procedures not in writing, fully followed
Seaway Pharma, Inc.	Drugs	09/21/2023	Training--operations, GMPs, written procedures
Seaway Pharma, Inc.	Drugs	09/21/2023	Sanitation--buildings not clean, free of infestation
Seaway Pharma, Inc.	Drugs	09/21/2023	Cleaning / Sanitizing / Maintenance
Seaway Pharma, Inc.	Drugs	09/21/2023	Cleaning SOPs/instructions
Seaway Pharma, Inc.	Drugs	09/21/2023	Calibration/Inspection/Checking not done
Seaway Pharma, Inc.	Drugs	09/21/2023	Component identity verification
Seaway Pharma, Inc.	Drugs	09/21/2023	Reports of Analysis (Components)
Seaway Pharma, Inc.	Drugs	09/21/2023	Absence of Written Procedures
Seaway Pharma, Inc.	Drugs	09/21/2023	Stability sample storage conditions described
Seaway Pharma, Inc.	Drugs	09/21/2023	Reserve samples identified, representative, stored
Seaway Pharma, Inc.	Drugs	09/21/2023	Items to cover on annual reviews
Seaway Pharma, Inc.	Drugs	09/21/2023	Investigations of discrepancies, failures
Seaway Pharma, Inc.	Drugs	09/21/2023	Complete Test Data