There were 16 companies in cities associated with Suffolk County that received FDA citations as a result of 16 inspections conducted in the county throughout 2023, 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 year.
Of the 41 citations issued, the most common citations were ‘You did not take a reasonable measure or precaution related to personnel practices’ and ‘Procedures for corrective and preventive action have not been adequately established’.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.
Of the companies cited, 16 should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (6.3%).
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.
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, according to its website.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Air Culinaire Worldwide, LLC | Food and Cosmetics | 02/06/2023 | Personnel |
| Air Culinaire Worldwide, LLC | Food and Cosmetics | 02/06/2023 | Sanitary operations – Plant sanitation |
| Air Culinaire Worldwide, LLC | Food and Cosmetics | 02/06/2023 | Sanitary facilities and controls |
| Atlantic Animal Health, Inc. | Veterinary | 03/16/2023 | Establish reliability of supplier’s C of A |
| Boston Tomato, Inc. | Food and Cosmetics | 06/22/2023 | Develop FSVP |
| Boston Tomato, Inc. | Food and Cosmetics | 06/22/2023 | Good compliance standing |
| Chinese Scallion Pie, Inc. | Food and Cosmetics | 12/28/2023 | Food safety plan |
| Denarius Trading Corporation | Food and Cosmetics | 04/14/2023 | Importer verification |
| GHE Group, Company | Food and Cosmetics | 01/17/2023 | Sanitary operations – Plant maintenance |
| GHE Group, Company | Food and Cosmetics | 01/17/2023 | Pest control |
| GHE Group, Company | Food and Cosmetics | 01/17/2023 | Sanitation monitoring |
| Gelesis, Inc. | Devices | 01/25/2023 | Evaluation of suppliers, contractors, etc., requirements |
| Gelesis, Inc. | Devices | 01/25/2023 | Lack of or inadequate procedures |
| John Mantia & Sons Company, Inc. | Food and Cosmetics | 01/31/2023 | HACCP plan implementation |
| John Mantia & Sons Company, Inc. | Food and Cosmetics | 01/31/2023 | Verification – record review – frequency |
| Lun Fat Produce, Inc. | Food and Cosmetics | 07/20/2023 | Grounds |
| Lun Fat Produce, Inc. | Food and Cosmetics | 07/20/2023 | Sanitary operations – Plant maintenance |
| Lun Fat Produce, Inc. | Food and Cosmetics | 07/20/2023 | Pest control |
| Lun Fat Produce, Inc. | Food and Cosmetics | 07/20/2023 | Sanitary facilities and controls |
| Lun Fat Produce, Inc. | Food and Cosmetics | 07/20/2023 | Equipment and utensils – Design and maintenance |
| Lun Fat Produce, Inc. | Food and Cosmetics | 07/20/2023 | Manufacturing, processing, packing, holding – Controls |
| PHASE-N Corporation | Devices | 02/09/2023 | Lack of or inadequate procedures |
| RRG Holton, LLC | Food and Cosmetics | 08/18/2023 | Personnel |
| RRG Holton, LLC | Food and Cosmetics | 08/18/2023 | Sanitation of food-contact surfaces – Frequency |
| RRG Holton, LLC | Food and Cosmetics | 08/18/2023 | Plant operations – Precautions |
| Seven Hills Farmstead, LLC | Food and Cosmetics | 07/20/2023 | Personnel |
| Seven Hills Farmstead, LLC | Food and Cosmetics | 07/20/2023 | Plant operations – Precautions |
| Seven Hills Farmstead, LLC | Food and Cosmetics | 07/20/2023 | Raw materials controls – Natural toxins |
| TEI Biosciences, Inc. | Devices | 05/17/2023 | Contamination control, Lack of or inadequate procedures |
| TEI Biosciences, Inc. | Devices | 05/17/2023 | Software validation for automated processes |
| TEI Biosciences, Inc. | Devices | 05/17/2023 | Remedial action |
| TEI Biosciences, Inc. | Devices | 05/17/2023 | Lack of or inadequate process validation |
| TEI Biosciences, Inc. | Devices | 05/17/2023 | Nonconforming product, Lack of or inadequate procedures |
| TEI Biosciences, Inc. | Devices | 05/17/2023 | Lack of or inadequate procedures |
| TEI Biosciences, Inc. | Devices | 05/17/2023 | Lack of or inadequate procedures for storage. |
| The Alphas Company, Inc. | Food and Cosmetics | 01/24/2023 | Develop FSVP |
| Vertex Pharmaceuticals Incorporated | Drugs | 05/04/2023 | Cleaning SOP/inspection |
| Whele, LLC | Devices | 07/18/2023 | Report of death, injury |
| Whele, LLC | Devices | 07/18/2023 | Nonconforming product control |
| Whele, LLC | Devices | 07/18/2023 | Lack of or inadequate procedures |
| Whele, LLC | Devices | 07/18/2023 | Lack of or inadequate complaint procedures |
