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.
| 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 |











