Bean Town Times

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