There was one company in a city associated with Erie County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 66.7% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been established.
- Software used as part of production has not been adequately validated for its intended use according to an established protocol.
- A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
The company cited should take a voluntary action to correct its managing operations.
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 |
|---|---|---|---|
| Hard Manufacturing Company, Inc. | Devices | 03/06/2025 | Process control procedures, Lack of or inadequate procedures |
| Hard Manufacturing Company, Inc. | Devices | 03/06/2025 | Software validation for automated processes |
| Hard Manufacturing Company, Inc. | Devices | 03/06/2025 | Lack of or inadequate process validation |
| Hard Manufacturing Company, Inc. | Devices | 03/06/2025 | Documentation |
| Hard Manufacturing Company, Inc. | Devices | 03/06/2025 | Lack of or inadequate procedures |
