There were two companies in cities associated with Seneca County that received FDA citations as a result of two inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 100% increase over the number of companies cited in the previous year.
The citations in the county include:
- The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
- The design history file was not established and does not demonstrate that the design was developed following the approved design plan.
- Process validation activities and results have not been adequately documented.
Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| American Contract Systems, Inc. | Devices | 08/14/2024 | Lack of or inadequate organizational structure |
| American Contract Systems, Inc. | Devices | 08/14/2024 | Design history file |
| American Contract Systems, Inc. | Devices | 08/14/2024 | Documentation |
| American Contract Systems, Inc. | Devices | 08/14/2024 | Lack of or inadequate receiving acceptance procedures |
| Archer Daniels Midland Company | Veterinary | 01/08/2024 | Holding and Distribution |
