There were two companies in a city associated with Monroe County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2025, 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 quarter.
The citations in the county include:
- You did not develop an FSVP.
- Your hazard analysis did not identify a hazard that requires a control.
- You did not ensure that your electronic mail address and the unique facility identifier recognized as acceptable by FDA was/were provided electronically when filing entry with the U.S. Customs and Border Protection.
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 |
|---|---|---|---|
| Caliber Imaging and Diagnostics, Inc. | Devices | 02/06/2025 | Lack of or inadequate procedures |
| Wegmans Food Markets, Inc. | Food and Cosmetics | 02/04/2025 | Develop FSVP |
| Wegmans Food Markets, Inc. | Food and Cosmetics | 02/04/2025 | Hazard analysis biological, chemical, physical |
| Wegmans Food Markets, Inc. | Food and Cosmetics | 02/04/2025 | Identification – entry |
