There were two companies in a city associated with Erie County that received FDA citations as a result of two inspections conducted in the county over the second quarter of 2025, 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 quarter.
The citations in the county include:
- Procedures for management review have not been established.
- Procedures for design review have not been adequately established.
- Procedures for corrective and preventive action have not been adequately established.
Both companies cited should take voluntary actions to correct their 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 |
|---|---|---|---|
| Mayer Bros. Apple Products, Inc. | Food and Cosmetics | 05/16/2025 | Pest control |
| Mayer Bros. Apple Products, Inc. | Food and Cosmetics | 05/16/2025 | Verification activities – minimum |
| Pedia Parents, Inc. | Devices | 04/24/2025 | Management review – Lack of or inadequate procedures |
| Pedia Parents, Inc. | Devices | 04/24/2025 | Design review – Lack of or inadequate procedures |
| Pedia Parents, Inc. | Devices | 04/24/2025 | Lack of or inadequate procedures |
