NYC Gazette

There were 39 companies in cities associated with Bronx County that received FDA citations as a result of 39 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 40% decrease from the number of companies cited in the previous year.

Of the 97 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 the Biologics sector.

Of the companies cited, 37 should take voluntary actions to correct their managing operations (94.9%). Additionally, two companies had to take regulatory and/or administrative actions (5.1%).

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
Aaron Gourmet Food Imports, Inc.	Food and Cosmetics	06/01/2023	Very small importer assurances, supplier
Americord Registry, LLC	Biologics	01/13/2023	Approval and review of procedures
Americord Registry, LLC	Biologics	01/13/2023	Validation lacking for sterile drug products
Americord Registry, LLC	Biologics	01/13/2023	Scientifically sound laboratory controls
Americord Registry, LLC	Biologics	01/13/2023	Microbiological testing
Americord Registry, LLC	Biologics	01/13/2023	Dates not included for each significant step
Americord Registry, LLC	Biologics	01/13/2023	Testing, screening, donor eligibility procedures
Americord Registry, LLC	Biologics	01/13/2023	Risk factors, clinical evidence
Americord Registry, LLC	Biologics	01/13/2023	Birth mother sample not tested
Americord Registry, LLC	Biologics	01/13/2023	All core requirements covered in program
Americord Registry, LLC	Biologics	01/13/2023	Deviations--Investigation, documenting, trending
Americord Registry, LLC	Biologics	01/13/2023	Documentation of maintenance and cleaning
Americord Registry, LLC	Biologics	01/13/2023	Verification/validation
Americord Registry, LLC	Biologics	01/13/2023	Process validation procedures
Americord Registry, LLC	Biologics	01/13/2023	Accurate, indelible, legible
Americord Registry, LLC	Biologics	01/13/2023	Records incomplete
Amorino Trading, LLC	Food and Cosmetics	03/02/2023	Develop FSVP
Applevalley Organics, Corporation, Inc.	Veterinary	08/16/2023	Develop FSVP
BonBon NYC, LLC.	Food and Cosmetics	02/24/2023	Very small importer assurances, supplier
Coosemans New York, Inc.	Food and Cosmetics	02/24/2023	Develop FSVP
Coosemans New York, Inc.	Food and Cosmetics	02/24/2023	Raw agricultural commodity hazard
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
Delsam Pharma, LLC	Drugs	03/24/2023	Lack of quality control unit
Delsam Pharma, LLC	Drugs	03/24/2023	Storage under appropriate conditions
Delsam Pharma, LLC	Drugs	03/24/2023	Recall facilitation
Delsam Pharma, LLC	Drugs	03/24/2023	Items to cover on annual reviews
Delsam Pharma, LLC	Drugs	03/24/2023	Procedures to be written and followed
E. Armata, Inc.	Food and Cosmetics	03/21/2023	Develop FSVP
Eileen's Special Cheesecake, Inc.	Food and Cosmetics	01/24/2023	Pest control
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
G21 USA, Inc.	Devices	07/25/2023	Training - Lack of or inadequate procedures
G21 USA, Inc.	Devices	07/25/2023	Lack of or inadequate procedures
G21 USA, Inc.	Devices	07/25/2023	Lack of or inadequate complaint procedures
Gurum Corporation	Food and Cosmetics	08/15/2023	Develop FSVP
J Margiotta Company, LLC	Food and Cosmetics	01/31/2023	Develop FSVP
J&H Imports Services Corporation	Food and Cosmetics	08/02/2023	Develop FSVP
Juice Press, LLC	Food and Cosmetics	03/14/2023	Develop FSVP
Kofinas Fertility Group	Biologics	07/25/2023	Determination based on screening and testing
Kofinas Fertility Group	Biologics	07/25/2023	Responsible person to determine, document
Kofinas Fertility Group	Biologics	07/25/2023	Accurate, indelible, legible
Kyewaa, LLC	Food and Cosmetics	12/19/2023	Develop FSVP
LA Dulceria, Inc.	Food and Cosmetics	02/08/2023	Develop FSVP
MTV Foods	Food and Cosmetics	09/08/2023	Importer verification
Manhattan Fertility Services, LLC	Biologics	04/06/2023	Labeled re: biohazard, risks, test results
Manhattan Fertility Services, LLC	Biologics	04/06/2023	Risk factors, clinical evidence
Molino Food Livel, Corp.	Food and Cosmetics	09/11/2023	Very small importer assurances, supplier
Montefiore Medical Center Blood Bank	Biologics	05/18/2023	Qualifications of responsible personnel
Montefiore Medical Center Blood Bank	Biologics	05/18/2023	Establish, maintain and follow manufacturing SOPs
Montefiore Medical Center Blood Bank	Biologics	05/18/2023	Concurrent documentation
Mrinal M. Gounder, M.D.	Drugs	03/03/2023	FD-1572, protocol compliance
Mrinal M. Gounder, M.D.	Drugs	03/03/2023	Safety Reports - Serious Events
N. Y. S. Psychiatric Institute IRB	Drugs	02/02/2023	ClincialTrials.gov statement
N. Y. S. Psychiatric Institute IRB	Drugs	02/02/2023	Prompt reporting of unanticipated problems
N. Y. S. Psychiatric Institute IRB	Drugs	02/02/2023	Prompt reporting of noncompliance
N. Y. S. Psychiatric Institute IRB	Drugs	02/02/2023	Members present for review
N. Y. S. Psychiatric Institute IRB	Drugs	02/02/2023	Minor changes
New Hope Fertility Center	Biologics	03/03/2023	Responsible person to determine, document
New Hope Fertility Center	Biologics	03/03/2023	Completion of eligibility determination
New Hope Fertility Center	Biologics	03/03/2023	Eligibility not required--warning labels
New York Blood Center Enterprises	Biologics	07/06/2023	Maintenance - tracing
New York Blood Center Enterprises	Biologics	07/06/2023	When to report
New York Blood Center Enterprises	Biologics	07/06/2023	Following manufacturer's instructions
New York Blood Center Enterprises	Biologics	07/06/2023	Establish, maintain and follow manufacturing SOPs
New York Blood Center Enterprises	Biologics	07/06/2023	Thorough investigations
New York Blood Center Enterprises	Biologics	07/06/2023	Required records
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
Reyes Produce Corporation	Food and Cosmetics	03/17/2023	Develop FSVP
Shneiders USA, Inc.	Food and Cosmetics	01/19/2023	Develop FSVP
Sojitz Corporation of America	Veterinary	08/11/2023	Develop FSVP
Sojitz Corporation of America	Veterinary	08/11/2023	Record - translate to English
Sweet Sam's Baking Company, LLC	Food and Cosmetics	07/20/2023	Personnel
Sweet Sam's Baking Company, LLC	Food and Cosmetics	07/20/2023	Pest control
TMRW Life Sciences, Inc.	Devices	10/24/2023	DHR - not or inadequately maintained
Wako Inflight Service, Inc.	Food and Cosmetics	03/01/2023	Cleaning and sanitizing substances - Safe and adequate
Wako Inflight Service, Inc.	Food and Cosmetics	03/01/2023	Manufacturing, processing, packing, holding - Controls
Wako Inflight Service, Inc.	Food and Cosmetics	03/01/2023	Calibration - adequacy
Wako Inflight Service, Inc.	Food and Cosmetics	03/01/2023	Plumbing design, installation, maintenance
Wako Inflight Service, Inc.	Food and Cosmetics	03/01/2023	Maintained in good repair
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