Westchester Reporter

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

This is a 44.4% decrease from the number of companies cited in the previous year.

Of the 18 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.

Of the companies cited, four should take voluntary actions to correct their managing operations (80%). Additionally, one company had to take regulatory and/or administrative actions (20%).

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
D&G Produce, Inc.	Food and Cosmetics	02/02/2023	Develop FSVP
Harvest Commodities Marketing, Inc.	Food and Cosmetics	12/20/2023	Develop FSVP
Harvest Commodities Marketing, Inc.	Food and Cosmetics	12/20/2023	Reevaluate - 3 years
Harvest Commodities Marketing, Inc.	Food and Cosmetics	12/20/2023	Supplier verification - follow written procedures
Harvest Commodities Marketing, Inc.	Food and Cosmetics	12/20/2023	Supplier verification assurance
Homeocare Laboratories, Inc.	Drugs	02/21/2023	Procedures not in writing, fully followed
Homeocare Laboratories, Inc.	Drugs	02/21/2023	Equipment Design, Size and Location
Homeocare Laboratories, Inc.	Drugs	02/21/2023	Cleaning / Sanitizing / Maintenance
Homeocare Laboratories, Inc.	Drugs	02/21/2023	Quarantine Storage of Components
Homeocare Laboratories, Inc.	Drugs	02/21/2023	Rejecting When Specifications Not Met
Homeocare Laboratories, Inc.	Drugs	02/21/2023	Absence of Written Procedures
Homeocare Laboratories, Inc.	Drugs	02/21/2023	Homeopathic drugs, assessment of stability
Homeocare Laboratories, Inc.	Drugs	02/21/2023	Review of representative number of batches
Homeocare Laboratories, Inc.	Drugs	02/21/2023	Identification of Equipment and Lines
Homeocare Laboratories, Inc.	Drugs	02/21/2023	Extent of discrepancy, failure investigations
Ni-Company Enterprise, Inc.	Food and Cosmetics	11/16/2023	HACCP plan implementation
Ni-Company Enterprise, Inc.	Food and Cosmetics	11/16/2023	Sanitation monitoring
Yam Manager Delivery, LLC	Food and Cosmetics	08/01/2023	Develop FSVP