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 |
