How many companies in cities across Suffolk County received FDA citations in 2024?

How many companies in cities across Suffolk County received FDA citations in 2024?
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA — Official Website
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There were 21 companies in cities associated with Suffolk County that received FDA citations as a result of 22 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 4.5% decrease from the number of companies cited in the previous year.

Of the 113 citations issued, the most common citations include:

  • You did not exclude pests from your food plant to protect against contamination of food.
  • Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
  • Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

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 Drugs sector.

Of the companies cited, 21 should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (4.8%).

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.

According to its website, 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.

Companies Located Within Suffolk County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
AJES Pharmaceuticals, LLC Food and Cosmetics 12/09/2024 Specifications – components
AJES Pharmaceuticals, LLC Food and Cosmetics 12/09/2024 Specifications – finished dietary supplement
AJES Pharmaceuticals, LLC Food and Cosmetics 12/09/2024 Reprocessed – rejected dietary supplement
AJES Pharmaceuticals, LLC Food and Cosmetics 12/09/2024 Master manufacturing record – record requirements
AJES Pharmaceuticals, LLC Food and Cosmetics 12/09/2024 Batch record – complete
AJES Pharmaceuticals, LLC Food and Cosmetics 12/09/2024 Batch record – follow master
AJES Pharmaceuticals, LLC Food and Cosmetics 12/09/2024 Standard reference materials; criteria for selecting
AJES Pharmaceuticals, LLC Food and Cosmetics 12/09/2024 Written procedures – follow; product complaint
American Regent, Inc. Drugs 04/24/2024 Air Supply
American Regent, Inc. Drugs 04/24/2024 Environmental Monitoring System
American Regent, Inc. Drugs 04/24/2024 Equipment Design, Size and Location
American Regent, Inc. Drugs 04/24/2024 Computer control of master formula records
American Regent, Inc. Drugs 04/24/2024 Absence of Written Procedures
American Regent, Inc. Drugs 04/24/2024 Validation lacking for sterile drug products
American Regent, Inc. Drugs 04/24/2024 Storage under appropriate conditions
American Regent, Inc. Veterinary 04/24/2024 Air Supply
American Regent, Inc. Veterinary 04/24/2024 Environmental Monitoring System
American Regent, Inc. Veterinary 04/24/2024 Equipment Design, Size and Location
American Regent, Inc. Veterinary 04/24/2024 Computer control of master formula records
American Regent, Inc. Veterinary 04/24/2024 Absence of Written Procedures
American Regent, Inc. Veterinary 04/24/2024 Validation lacking for sterile drug products
American Regent, Inc. Veterinary 04/24/2024 Storage under appropriate conditions
Cobblestone Bakery, CORP Food and Cosmetics 11/18/2024 Sanitary facilities and controls
Cobblestone Bakery, CORP Food and Cosmetics 11/18/2024 Hazard analysis – Identification of hazard
Cobblestone Bakery, CORP Food and Cosmetics 11/18/2024 Supply-chain program – Assurance (Adequate)
Country Life, LLC Food and Cosmetics 07/12/2024 Personnel – hygienic practices
Country Life, LLC Food and Cosmetics 07/12/2024 Specifications – component identity
Country Life, LLC Food and Cosmetics 07/12/2024 Specifications-component purity, strength, composition
Country Life, LLC Food and Cosmetics 07/12/2024 Specifications – contamination limits
Country Life, LLC Food and Cosmetics 07/12/2024 Specifications – identity, purity, strength, composition
Country Life, LLC Food and Cosmetics 07/12/2024 Tests, examinations – scientifically valid
Country Life, LLC Food and Cosmetics 07/12/2024 Master manufacturing record theoretical and expected yield
Country Life, LLC Food and Cosmetics 07/12/2024 Instructions; specifications; packaged, labeled
Country Life, LLC Food and Cosmetics 07/12/2024 Master manufacturing record – sampling, tests, examinations
Country Life, LLC Food and Cosmetics 07/12/2024 Batch record – initials; each step
Country Life, LLC Food and Cosmetics 07/12/2024 Hold – mix-up, contamination, deterioration
Elwood International, Inc. Food and Cosmetics 03/08/2024 Scheduled process
Elwood International, Inc. Food and Cosmetics 03/08/2024 Visible code
Elwood International, Inc. Food and Cosmetics 03/08/2024 Raw materials, packaging, finished product
Elwood International, Inc. Food and Cosmetics 03/08/2024 Maintenance of processing and production records
Elwood International, Inc. Food and Cosmetics 03/08/2024 Processing and production – required information
Elwood International, Inc. Food and Cosmetics 03/08/2024 Personnel
Elwood International, Inc. Food and Cosmetics 03/08/2024 Plant construction and design
Elwood International, Inc. Food and Cosmetics 03/08/2024 Pest control
Elwood International, Inc. Food and Cosmetics 03/08/2024 Hazard analysis – Identification of hazard
Elwood International, Inc. Food and Cosmetics 03/08/2024 Allergen preventive controls – Implement
Elwood International, Inc. Food and Cosmetics 03/08/2024 Sanitation preventive controls – Implement
Elwood International, Inc. Food and Cosmetics 03/08/2024 Process preventive controls – Appropriate (Adequate)
Elwood International, Inc. Food and Cosmetics 03/08/2024 Sanitation preventive controls – Appropriate (Adequate)
Elwood International, Inc. Food and Cosmetics 03/08/2024 Supply-chain program – Assurance (Adequate)
Keep Healthy, Inc. Food and Cosmetics 07/03/2024 Sanitary operations – Plant sanitation
LS Promotions, Inc. Food and Cosmetics 06/13/2024 Sanitary operations – Plant sanitation
LS Promotions, Inc. Drugs 05/02/2024 Approve or reject procedures or specs
LS Promotions, Inc. Drugs 05/02/2024 Calibration/Inspection/Checking not done
LS Promotions, Inc. Drugs 05/02/2024 Identity Testing of Each Component
LS Promotions, Inc. Drugs 05/02/2024 Absence of Written Procedures
LS Promotions, Inc. Drugs 05/02/2024 Actual vs. theoretical yields not determined
LS Promotions, Inc. Drugs 05/02/2024 Establishment of time limitations
LS Promotions, Inc. Drugs 05/02/2024 Strict control not exercised over labeling issued
LS Promotions, Inc. Drugs 05/02/2024 Storage under appropriate conditions
LS Promotions, Inc. Drugs 05/02/2024 Lack of written stability program
LS Promotions, Inc. Drugs 05/02/2024 Inspection of packaging and labeling area
LS Promotions, Inc. Drugs 05/02/2024 Labeling Control Records and Label Copies
Latinfood US, Corp. Food and Cosmetics 02/08/2024 Pest control
Latinfood US, Corp. Food and Cosmetics 02/08/2024 Importer verification
MediNutritionals Research, LLC Food and Cosmetics 02/22/2024 Written procedures – product complaint
Nestle Health Science, LLC. Food and Cosmetics 03/18/2024 Specifications met – identity, purity, strength, composition
Nestle Health Science, LLC. Food and Cosmetics 03/18/2024 Component – verify identity, dietary ingredient
Nutra Group, LLC Food and Cosmetics 06/10/2024 Written procedures – returned dietary supplement
Nutra Group, LLC Food and Cosmetics 06/10/2024 Written procedures – product complaint; review, investigate
Opti Source International Drugs 04/04/2024 Lack of quality control unit
Opti Source International Drugs 04/04/2024 Training , Education , Experience overall
Opti Source International Drugs 04/04/2024 Equipment Design, Size and Location
Opti Source International Drugs 04/04/2024 Written procedures not established/followed
Opti Source International Drugs 04/04/2024 Component identity verification
Opti Source International Drugs 04/04/2024 Rejecting When Specifications Not Met
Opti Source International Drugs 04/04/2024 Absence of Written Procedures
Opti Source International Drugs 04/04/2024 Testing and release for distribution
Opti Source International Drugs 04/04/2024 Adequate number of batches on stability
Opti Source International Drugs 04/04/2024 Review of representative number of batches
Opti Source International Drugs 04/04/2024 Prepared for each batch, include complete information
Optima Foods, Inc. Food and Cosmetics 04/11/2024 Personnel
Optima Foods, Inc. Food and Cosmetics 04/11/2024 Pest control
Optima Foods, Inc. Food and Cosmetics 04/11/2024 Sanitation of non-food-contact surfaces – Manner and frequency
Optima Foods, Inc. Food and Cosmetics 04/11/2024 Food safety plan
Optima Foods, Inc. Food and Cosmetics 04/11/2024 Hazard analysis
Optima Foods, Inc. Food and Cosmetics 04/11/2024 No HACCP plan
Optima Foods, Inc. Food and Cosmetics 04/11/2024 HACCP training or qualification
Optima Foods, Inc. Food and Cosmetics 04/11/2024 Sanitation Records
Optima Foods, Inc. Food and Cosmetics 04/11/2024 Importer verification
RMA Long Island IVF Biologics 02/09/2024 Testing, screening, donor eligibility procedures
RMA Long Island IVF Biologics 02/09/2024 Responsible person to determine, document
RMA Long Island IVF Biologics 02/09/2024 Accurate, indelible, legible
Radienz Living, LLC Drugs 01/11/2024 Equipment Design, Size and Location
Radienz Living, LLC Drugs 01/11/2024 Written procedures not established/followed
Radienz Living, LLC Drugs 01/11/2024 Computer control of master formula records
Radienz Living, LLC Drugs 01/11/2024 Control procedures to monitor and validate performance
Radienz Living, LLC Drugs 01/11/2024 Storage under appropriate conditions
Radienz Living, LLC Drugs 01/11/2024 Batch production and Batch Control Record Requirements
Savings Distributors, LLC Drugs 12/19/2024 Procedures not in writing, fully followed
Savings Distributors, LLC Drugs 12/19/2024 Absence of Written Procedures
Steinway Pasta & Gelati, Inc. Food and Cosmetics 08/01/2024 Sanitary operations – Plant maintenance
Steinway Pasta & Gelati, Inc. Food and Cosmetics 08/01/2024 Manufacturing, processing, packing, holding – Controls
Stony Brook Community Medical – Island Fertility, PC Biologics 05/28/2024 Testing, screening, donor eligibility procedures
Stony Brook Community Medical – Island Fertility, PC Biologics 05/28/2024 Determination based on screening and testing
Stony Brook Community Medical – Island Fertility, PC Biologics 05/28/2024 Donor testing not negative for CD agents
Stony Brook Community Medical – Island Fertility, PC Biologics 05/28/2024 Labeled re: biohazard, risks, test results
Stony Brook University Medical Center Biologics 03/07/2024 Thorough investigations
Stony Brook University Medical Center Biologics 03/07/2024 Establishment of spec., standards, and test procedures
Stony Brook University Medical Center Biologics 03/07/2024 Required records
U. S. Department of Veterans Affairs, Northport VA Medical Center Biologics 01/09/2024 Establish, maintain and follow manufacturing SOPs
U. S. Department of Veterans Affairs, Northport VA Medical Center Biologics 01/09/2024 Required records
United Guardian, Inc. Drugs 09/05/2024 Failure to develop written procedures


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