Suffolk Reporter

There were 21 companies in cities associated with Suffolk County that received FDA citations as a result of 21 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 68 citations issued, the most common citation was 'Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established'.

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 Devices sector.

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. M. Surgical, Inc.	Devices	10/20/2023	DMR - not or inadequately maintained
AMP Nutraceuticals	Food and Cosmetics	11/21/2023	Specifications - identity, purity, strength, composition
AMP Nutraceuticals	Food and Cosmetics	11/21/2023	Specifications met - identity, purity, strength, composition
AMP Nutraceuticals	Food and Cosmetics	11/21/2023	Component - verify identity, dietary ingredient
AMP Nutraceuticals	Food and Cosmetics	11/21/2023	Quality control - reject; specification not met
AMP Nutraceuticals	Food and Cosmetics	11/21/2023	Standard reference materials; criteria for selecting
Abel & Schafer, Inc.	Food and Cosmetics	01/25/2023	Equipment and utensils - Design and maintenance
Ackermann Usa, Inc.	Devices	08/04/2023	Lack of or inadequate receiving acceptance procedures
Ackermann Usa, Inc.	Devices	08/04/2023	Lack of or inadequate complaint procedures
All Star Specialties Corporation	Food and Cosmetics	02/22/2023	Plant operations - Precautions
Banyan USA, LLC	Devices	09/12/2023	Lack of Written MDR Procedures
Banyan USA, LLC	Devices	09/12/2023	Management review - defined interval, sufficient frequency
Banyan USA, LLC	Devices	09/12/2023	Quality Audit/Reaudit - conducted
Banyan USA, LLC	Devices	09/12/2023	Lack of procedures, or not maintained
Banyan USA, LLC	Devices	09/12/2023	Documented evaluation
Banyan USA, LLC	Devices	09/12/2023	Maintenance schedule, Lack of or inadequate schedule
Banyan USA, LLC	Devices	09/12/2023	Documentation
Banyan USA, LLC	Devices	09/12/2023	Incoming acceptance records, documentation
Banyan USA, LLC	Devices	09/12/2023	Lack of or inadequate complaint procedures
Bob Gosman Company, Inc.	Food and Cosmetics	10/19/2023	HACCP plan implementation
Bob Gosman Company, Inc.	Food and Cosmetics	10/19/2023	Food safety hazards
Bob Gosman Company, Inc.	Food and Cosmetics	10/19/2023	Critical limits
Bob Gosman Company, Inc.	Food and Cosmetics	10/19/2023	Verification procedures - adequacy
Bob Gosman Company, Inc.	Food and Cosmetics	10/19/2023	Signed and dated
Bob Gosman Company, Inc.	Food and Cosmetics	10/19/2023	Corrective action per predetermined plan
Bob Gosman Company, Inc.	Food and Cosmetics	10/19/2023	Verification - record review - frequency
Bob Gosman Company, Inc.	Food and Cosmetics	10/19/2023	Sanitation monitoring
Bob Gosman Company, Inc.	Food and Cosmetics	10/19/2023	Importer verification
Due Amici Imports, Inc.	Food and Cosmetics	03/23/2023	Develop FSVP
G Fuel, LLC	Food and Cosmetics	07/05/2023	Quality control - required operations product complaints
G Fuel, LLC	Food and Cosmetics	07/05/2023	Quality control operations - tests, examinations; results
In Store Distributors, Inc.	Food and Cosmetics	03/21/2023	Manufacturing, processing, packing, holding - Controls
La Ricura Foods, Ltd.	Food and Cosmetics	08/21/2023	Develop FSVP
Madcar A Division of Century Direct Solutions	Drugs	12/20/2023	Procedure Deviations Recorded and Justified
Madcar A Division of Century Direct Solutions	Drugs	12/20/2023	Actual vs. theoretical yields not determined
Madcar A Division of Century Direct Solutions	Drugs	12/20/2023	Strict control not exercised over labeling issued
Madcar A Division of Century Direct Solutions	Drugs	12/20/2023	Storage under appropriate conditions
Madcar A Division of Century Direct Solutions	Drugs	12/20/2023	Labeling Control Records and Label Copies
Mirion Technologies	Devices	02/10/2023	Document change records, maintained.
Mirion Technologies	Devices	02/10/2023	DHR - not or inadequately maintained
Muscle Sport Products, LLC	Food and Cosmetics	05/09/2023	Written procedures - quality control operations
New York Blood Center Enterprises	Biologics	12/22/2023	Following manufacturer's instructions
New York Blood Center Enterprises	Biologics	12/22/2023	Establish, maintain and follow manufacturing SOPs
New York Blood Center Enterprises	Biologics	12/22/2023	Person performing, test results, interpretation
Phoenix Wipes, Inc.	Drugs	12/19/2023	Procedures not in writing, fully followed
Phoenix Wipes, Inc.	Drugs	12/19/2023	GMP Training Frequency
Phoenix Wipes, Inc.	Drugs	12/19/2023	Equipment Design, Size and Location
Phoenix Wipes, Inc.	Drugs	12/19/2023	Written procedures not established/followed
Phoenix Wipes, Inc.	Drugs	12/19/2023	Component identity verification
Phoenix Wipes, Inc.	Drugs	12/19/2023	Absence of Written Procedures
Phoenix Wipes, Inc.	Drugs	12/19/2023	Expiration date lacking
Phoenix Wipes, Inc.	Drugs	12/19/2023	Record maintenance 1 year (except exempt OTC)
Phoenix Wipes, Inc.	Drugs	12/19/2023	Records reviewed annually
Red Medical Solutions, Inc.	Devices	03/22/2023	Lack of or inadequate procedures
Red Medical Solutions, Inc.	Devices	03/22/2023	Lack of or inadequate complaint procedures
Sleep Joy International, LLC	Devices	01/20/2023	Lack of Written MDR Procedures
Sleep Joy International, LLC	Devices	01/20/2023	Quality System Procedures
Sleep Joy International, LLC	Devices	01/20/2023	Design Validation - Risk analysis not performed/inadequate
Sleep Joy International, LLC	Devices	01/20/2023	Design history file
Spirit Pharmaceuticals	Drugs	11/01/2023	Computer control of master formula records
Spirit Pharmaceuticals	Drugs	11/01/2023	Reports of Analysis (Components)
Spirit Pharmaceuticals	Drugs	11/01/2023	Lack of written stability program
Stony Brook University Medical Center	Biologics	02/07/2023	Establish, maintain and follow manufacturing SOPs
Stony Brook University Medical Center	Biologics	02/07/2023	Required records
Stony Brook University Medical Center	Biologics	02/07/2023	Biological product deviation report
W. A. Baum Company, Inc.	Devices	11/06/2023	Lack of Written MDR Procedures
W. A. Baum Company, Inc.	Devices	11/06/2023	Evaluation of suppliers, contractors, etc., requirements
W. A. Baum Company, Inc.	Devices	11/06/2023	Documentation