NYC Gazette

There were 10 companies in cities associated with Bronx 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 unchanged from the number of companies cited in the previous quarter.

Of the 24 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
A Life Wholesale	Food and Cosmetics	10/10/2023	Develop FSVP
Crown Fish, LLC	Food and Cosmetics	10/24/2023	Critical limits
Crown Fish, LLC	Food and Cosmetics	10/24/2023	Monitoring - adequacy
Crown Fish, LLC	Food and Cosmetics	10/24/2023	Corrective action plan
Crown Fish, LLC	Food and Cosmetics	10/24/2023	Sanitation monitoring
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
Kyewaa, LLC	Food and Cosmetics	12/19/2023	Develop FSVP
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
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
Wild Edibles, Inc.	Food and Cosmetics	12/07/2023	HACCP plan implementation
Wild Edibles, Inc.	Food and Cosmetics	12/07/2023	Sanitation monitoring
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