Nassau Standard

There were 10 companies in cities associated with Nassau County that received FDA citations as a result of 10 inspections conducted in the county over the fourth quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 66.7% increase over the number of companies cited in the previous quarter.

Of the 31 citations issued, the most common citation was 'You did not develop an FSVP'.

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 .

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.

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
Alk-abello, Inc.	Biologics	10/17/2023	Written record of investigation incomplete
Bagels By Bell, Ltd.	Food and Cosmetics	12/05/2023	Personnel
Bagels By Bell, Ltd.	Food and Cosmetics	12/05/2023	Pest control
Bagels By Bell, Ltd.	Food and Cosmetics	12/05/2023	Sanitary facilities and controls
Bagels By Bell, Ltd.	Food and Cosmetics	12/05/2023	Manufacturing, processing, packing, holding - Controls
Chief Import & Export, Corp.	Food and Cosmetics	12/08/2023	Develop FSVP
Chief Import & Export, Corp.	Food and Cosmetics	12/08/2023	Hazard analysis biological, chemical, physical
Chief Import & Export, Corp.	Food and Cosmetics	12/08/2023	Document review entity's hazard analysis
Chief Import & Export, Corp.	Food and Cosmetics	12/08/2023	Evaluation - performance, risk
Chief Import & Export, Corp.	Food and Cosmetics	12/08/2023	Approved supplier procedures - importer established
Chief Import & Export, Corp.	Food and Cosmetics	12/08/2023	Verification activity before import, periodically
Fougera Pharmaceuticals, Inc.	Veterinary	11/17/2023	Investigations of discrepancies, failures
Huron Tool & Cutter Grinding Company	Devices	12/05/2023	Documentation
Life Plus Style Gourmet, LLC	Food and Cosmetics	12/12/2023	Develop FSVP
Life Plus Style Gourmet, LLC	Food and Cosmetics	12/12/2023	Supplier approval - document
Life Plus Style Gourmet, LLC	Food and Cosmetics	12/12/2023	Audit - document
Life Plus Style Gourmet, LLC	Food and Cosmetics	12/12/2023	Verification activity review, assess
Life Plus Style Gourmet, LLC	Food and Cosmetics	12/12/2023	Record - sign, date
Natars NY Food, Corp.	Food and Cosmetics	12/27/2023	Develop FSVP
New York Blood Center Enterprises	Biologics	10/27/2023	Written calibration / inspection records not kept
New York Blood Center Enterprises	Biologics	10/27/2023	Following manufacturer's instructions
New York Blood Center Enterprises	Biologics	10/27/2023	Establish, maintain and follow manufacturing SOPs
New York Blood Center Enterprises	Biologics	10/27/2023	Required records
Northern Food I/E, Inc.	Food and Cosmetics	10/31/2023	Develop FSVP
Northern Food I/E, Inc.	Food and Cosmetics	10/31/2023	Record - English
iTreat, Inc.	Food and Cosmetics	10/31/2023	Develop FSVP
iTreat, Inc.	Food and Cosmetics	10/31/2023	Hazard analysis biological, chemical, physical
iTreat, Inc.	Food and Cosmetics	10/31/2023	Evaluation - performance, risk
iTreat, Inc.	Food and Cosmetics	10/31/2023	Approved supplier procedures - importer established
iTreat, Inc.	Food and Cosmetics	10/31/2023	Supplier verification - establish written procedures
iTreat, Inc.	Food and Cosmetics	10/31/2023	Verification activity assurance