There were two companies in cities associated with Plymouth 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 a 100% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Your plant was not constructed and designed to facilitate maintenance and sanitary operations.
- You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against contamination of food.
- Your hazard analysis did not identify a hazard that required a preventive control.
The companies cited were involved in either Food and Cosmetics or Devices sectors.
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 |
|---|---|---|---|
| Elie Baking Corporation | Food and Cosmetics | 01/28/2025 | Plant construction and design |
| Elie Baking Corporation | Food and Cosmetics | 01/28/2025 | Sanitation of food-contact surfaces – Frequency |
| Elie Baking Corporation | Food and Cosmetics | 01/28/2025 | Hazard analysis – Identification of hazard |
| Elie Baking Corporation | Food and Cosmetics | 01/28/2025 | Process preventive controls – Appropriate (Adequate) |
| Saphena Medical, Inc. | Devices | 03/04/2025 | Individual Report of Malfunction |
| Saphena Medical, Inc. | Devices | 03/04/2025 | Lack of or inadequate procedures |
| Saphena Medical, Inc. | Devices | 03/04/2025 | Lack of or inadequate complaint procedures |
