There were eight companies in cities associated with Suffolk County that received FDA citations as a result of eight inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 55.6% decrease from the number of companies cited in the previous year.
Of the 18 citations issued, the most common citation was ‘Your hazard analysis did not identify a hazard that required a preventive control’.
Most of the companies cited were involved in the Food and Cosmetics sector.
All of the 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 |
|---|---|---|---|
| A. B. Seafood, LLC | Food and Cosmetics | 01/25/2024 | Food safety hazards |
| Alexion Pharmaceuticals, Inc. | Drugs | 11/07/2024 | Failure to develop written procedures |
| Alexion Pharmaceuticals, Inc. | Drugs | 11/07/2024 | Failure to review ADE information |
| Alexion Pharmaceuticals, Inc. | Drugs | 11/07/2024 | Late submission of 15-day report |
| Alexion Pharmaceuticals, Inc. | Drugs | 11/07/2024 | Late submission of an ICSR |
| Commonwealth of Massachusetts Department of Mental Health CRRC | Devices | 08/28/2024 | IRB registration information |
| Commonwealth of Massachusetts Department of Mental Health CRRC | Devices | 08/28/2024 | Method to keep members advised |
| Commonwealth of Massachusetts Department of Mental Health CRRC | Devices | 08/28/2024 | Minutes of IRB meetings |
| Commonwealth of Massachusetts Department of Mental Health CRRC | Devices | 08/28/2024 | List of members |
| Flynn Cruiseport Boston @ Black Falcon Terminal | Food and Cosmetics | 07/25/2024 | Plumbing design, installation, maintenance |
| Golden Cannoli Shells Company, Inc. | Food and Cosmetics | 03/04/2024 | Hazard analysis – Identification of hazard |
| Infinite Herbs, LLC | Food and Cosmetics | 08/08/2024 | Hazard analysis – Identification of hazard |
| Infinite Herbs, LLC | Food and Cosmetics | 08/08/2024 | Process preventive controls – Implementation records |
| Patrick Y. Wen, M.D. | Biologics | 06/25/2024 | New observations, adverse effects and risks |
| Snipped Fresh Produce, Inc. | Food and Cosmetics | 01/23/2024 | Sanitary operations – Plant maintenance |
| Snipped Fresh Produce, Inc. | Food and Cosmetics | 01/23/2024 | Sanitary facilities and controls |
| Snipped Fresh Produce, Inc. | Food and Cosmetics | 01/23/2024 | Hazard analysis – Identification of hazard |
| Snipped Fresh Produce, Inc. | Food and Cosmetics | 01/23/2024 | Process preventive controls – Implement |
