Nassau Standard

There were 26 companies in cities associated with Nassau County that received FDA citations as a result of 26 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 25.7% decrease from the number of companies cited in the previous year.

Of the 81 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 either Devices or Biologics sectors.

Of the companies cited, 25 should take voluntary actions to correct their managing operations (96.2%). Additionally, one company had to take regulatory and/or administrative actions (3.8%).

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
Andrew Sapienza Bakery, Inc.	Food and Cosmetics	01/24/2023	Sanitary operations - Plant maintenance
Andrew Sapienza Bakery, Inc.	Food and Cosmetics	01/24/2023	Sanitary operations - Plant sanitation
Andrew Sapienza Bakery, Inc.	Food and Cosmetics	01/24/2023	Equipment and utensils - Design and maintenance
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
Blue Stone Import USA, Inc.	Food and Cosmetics	03/27/2023	Develop FSVP
Blue Stone Import USA, Inc.	Food and Cosmetics	03/27/2023	Document review entity's hazard analysis
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
Fresh Produce Import & Export, Inc.	Food and Cosmetics	07/10/2023	Develop FSVP
Gate Gourmet, Inc.	Food and Cosmetics	04/17/2023	Sanitary operations - Plant maintenance
Gate Gourmet, Inc.	Food and Cosmetics	04/17/2023	Cleaning and sanitizing substances - Safe and adequate
Gate Gourmet, Inc.	Food and Cosmetics	04/17/2023	Toxic chemicals - Identified, held, stored
Gate Gourmet, Inc.	Food and Cosmetics	04/17/2023	Manufacturing, processing, packing, holding - Controls
Huron Tool & Cutter Grinding Company	Devices	12/05/2023	Documentation
J2NY Manufacturing & Distribution, LLC	Food and Cosmetics	04/05/2023	Process filing
J2NY Manufacturing & Distribution, LLC	Food and Cosmetics	04/05/2023	Approved school
J2NY Manufacturing & Distribution, LLC	Food and Cosmetics	04/05/2023	Code - required elements
J2NY Manufacturing & Distribution, LLC	Food and Cosmetics	04/05/2023	Raw materials, packaging, finished product
J2NY Manufacturing & Distribution, LLC	Food and Cosmetics	04/05/2023	Maintenance of processing and production records
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
Lions Eye Bank For Long Island	Biologics	08/03/2023	Accurate, indelible, legible
Lions Eye Bank For Long Island	Biologics	08/03/2023	Records maintained concurrently
Lions Eye Bank For Long Island	Biologics	08/03/2023	Establishing a system
Natars NY Food, Corp.	Food and Cosmetics	12/27/2023	Develop FSVP
Netech Corporation	Devices	04/14/2023	Lack of Written MDR Procedures
Netech Corporation	Devices	04/14/2023	Equipment control activity documentation
Netech Corporation	Devices	04/14/2023	DHR content
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
New York Reproductive Wellness Medicine, P.C.	Biologics	04/07/2023	Determination based on screening and testing
New York Reproductive Wellness Medicine, P.C.	Biologics	04/07/2023	Name and personal info on accompanying records
North Shore University Hospital Northwell Health	Biologics	04/26/2023	Who must report - manufacturer
North Shore University Hospital Northwell Health	Biologics	04/26/2023	Establish, maintain and follow manufacturing SOPs
North Shore University Hospital Northwell Health	Biologics	04/26/2023	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
Oximeter Plus, Inc.	Devices	07/21/2023	Nonconforming product, Lack of or inadequate procedures
Quesos La Ricura, Ltd.	Food and Cosmetics	08/23/2023	Hazard analysis - Identification of hazard
Quesos La Ricura, Ltd.	Food and Cosmetics	08/23/2023	HACCP training or qualification
Quesos La Ricura, Ltd.	Food and Cosmetics	08/23/2023	Importer verification
Sciarra Laboratories, Inc.	Drugs	08/07/2023	Procedures not in writing, fully followed
Sciarra Laboratories, Inc.	Drugs	08/07/2023	Training--operations, GMPs, written procedures
Sciarra Laboratories, Inc.	Drugs	08/07/2023	Control procedures to monitor and validate performance
Sciarra Laboratories, Inc.	Drugs	08/07/2023	Following/documenting laboratory controls
Sciarra Laboratories, Inc.	Drugs	08/07/2023	Establishment of calibration procedures
Sciarra Laboratories, Inc.	Drugs	08/07/2023	Written program not followed
US Merchandise, LLC	Devices	06/28/2023	Lack of Written MDR Procedures
US Merchandise, LLC	Devices	06/28/2023	Lack of or inadequate complaint procedures
Vasomedical, Inc.	Devices	01/09/2023	Management representative
Wm. E. Martin & Sons Company, Inc.	Food and Cosmetics	09/15/2023	Investigate
dnata US Inflight Catering, LLC	Food and Cosmetics	02/02/2023	Qualifications of individuals
dnata US Inflight Catering, LLC	Food and Cosmetics	02/02/2023	Personnel
dnata US Inflight Catering, LLC	Food and Cosmetics	02/02/2023	Toxic chemicals - Identified, held, stored
dnata US Inflight Catering, LLC	Food and Cosmetics	02/02/2023	Sanitary facilities and controls
dnata US Inflight Catering, LLC	Food and Cosmetics	02/02/2023	Manufacturing, processing, packing, holding - Controls
dnata US Inflight Catering, LLC	Food and Cosmetics	02/02/2023	Sanitation preventive controls - Implement
dnata US Inflight Catering, LLC	Food and Cosmetics	02/02/2023	Reanalysis frequency
dnata US Inflight Catering, LLC	Food and Cosmetics	02/02/2023	Plumbing design, installation, maintenance
dnata US Inflight Catering, LLC	Food and Cosmetics	02/02/2023	Adequate facilities for cleaning, bactericidal treatment
dnata US Inflight Catering, LLC	Food and Cosmetics	02/02/2023	Maintained in good repair
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