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 in March, 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 month.
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 |
