NYC Gazette

There were 13 companies in cities associated with Kings County that received FDA citations as a result of 13 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 30% increase over the number of companies cited in the previous quarter.

Of the 30 citations issued, the most common citation was 'You did not exclude pests from your food plant to protect against contamination of food'.

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
Acme Smoked Fish Corporation	Food and Cosmetics	11/07/2023	Sanitation monitoring
Banner Smoked Fish, Inc.	Food and Cosmetics	11/22/2023	HACCP plan implementation
Banner Smoked Fish, Inc.	Food and Cosmetics	11/22/2023	Corrective action per predetermined plan
Banner Smoked Fish, Inc.	Food and Cosmetics	11/22/2023	Records entries - timing
Cannoli Plus Enterprises, Inc.	Food and Cosmetics	11/06/2023	Personnel
Cannoli Plus Enterprises, Inc.	Food and Cosmetics	11/06/2023	Pest control
Desly International, Corp.	Food and Cosmetics	11/15/2023	Importer verification
Eye Bank For Sight Restoration, Inc.	Biologics	11/13/2023	Adequate control, proper conditions
Eye Bank For Sight Restoration, Inc.	Biologics	11/13/2023	Use prior to verification
Eye Bank For Sight Restoration, Inc.	Biologics	11/13/2023	Accurate, indelible, legible
Eye Bank For Sight Restoration, Inc.	Biologics	11/13/2023	Records incomplete
Eye Bank For Sight Restoration, Inc.	Biologics	11/13/2023	Records maintained concurrently
Joyva Corporation	Food and Cosmetics	12/07/2023	Allergen preventive controls - Implement
Joyva Corporation	Food and Cosmetics	12/07/2023	Supply-chain program - Implement
Mandalay Soy Products, Inc.	Food and Cosmetics	12/06/2023	Storage and Distribution
New York Presbyterian Hospital-Columbia University Med. Center	Biologics	11/28/2023	Equipment observed, standardized, calibrated
New York Presbyterian Hospital-Columbia University Med. Center	Biologics	11/28/2023	Establish, maintain and follow manufacturing SOPs
New York Presbyterian Hospital-Columbia University Med. Center	Biologics	11/28/2023	Concurrent documentation
New York Presbyterian Hospital-Columbia University Med. Center	Biologics	11/28/2023	Required records
New Yung Wah Trading, LLC	Food and Cosmetics	10/13/2023	Qualifications of individuals
New Yung Wah Trading, LLC	Food and Cosmetics	10/13/2023	Sanitary operations - Plant maintenance
New Yung Wah Trading, LLC	Food and Cosmetics	10/13/2023	Pest control
New Yung Wah Trading, LLC	Food and Cosmetics	10/13/2023	Manufacturing, processing, packing, holding - Controls
Pinnacle Fertility Labs New York	Biologics	12/14/2023	Testing, screening, donor eligibility procedures
Ports America, Inc.	Food and Cosmetics	10/10/2023	Prevention of contamination
Ports America, Inc.	Food and Cosmetics	10/10/2023	Signs for non-potable water
TMRW Life Sciences, Inc.	Devices	10/24/2023	DHR - not or inadequately maintained
Xtreem Pulse, LLC	Devices	10/13/2023	Design changes - Lack of or Inadequate Procedures
Xtreem Pulse, LLC	Devices	10/13/2023	Design history file
Xtreem Pulse, LLC	Devices	10/13/2023	Lack of or inadequate receiving acceptance procedures