There were 12 companies in cities associated with Nassau County that received FDA citations as a result of 12 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 53.8% decrease from the number of companies cited in the previous year.
Of the 47 citations issued, the most common citation was ‘You did not exclude pests from your food plant to protect against contamination of food’.
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 Devices sector.
Of the companies cited, 11 should take voluntary actions to correct their managing operations (91.7%). Additionally, one company had to take regulatory and/or administrative actions (8.3%).
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 |
|---|---|---|---|
| Advanced Back Technologies, Inc. | Devices | 10/31/2024 | Design changes – Lack of or Inadequate Procedures |
| Advanced Back Technologies, Inc. | Devices | 10/31/2024 | Supplier notification of changes |
| Advanced Back Technologies, Inc. | Devices | 10/31/2024 | Lack of or inadequate procedures |
| Advanced Back Technologies, Inc. | Devices | 10/31/2024 | DHR – not or inadequately maintained |
| DDC Technologies, Inc. | Devices | 09/06/2024 | Design history file |
| DDC Technologies, Inc. | Devices | 09/06/2024 | Environmental control Lack of or inadequate procedures |
| DDC Technologies, Inc. | Devices | 09/06/2024 | Lack of or inadequate procedures – Acceptance activities |
| DDC Technologies, Inc. | Devices | 09/06/2024 | Lack of or inadequate procedures |
| DDC Technologies, Inc. | Devices | 09/06/2024 | Lack of or inadequate complaint procedures |
| Global Imports and Exports | Food and Cosmetics | 01/17/2024 | Develop FSVP |
| Hahn’s Old Fashioned Cake Company, Inc. | Food and Cosmetics | 04/11/2024 | Pest control |
| Hahn’s Old Fashioned Cake Company, Inc. | Food and Cosmetics | 04/11/2024 | Sanitary facilities and controls |
| Hahn’s Old Fashioned Cake Company, Inc. | Food and Cosmetics | 04/11/2024 | Process control – Foreign objects |
| Hahn’s Old Fashioned Cake Company, Inc. | Food and Cosmetics | 04/11/2024 | Modified requirement: Temperature control – Implement |
| House of Spices India, Inc. | Food and Cosmetics | 02/09/2024 | Develop FSVP |
| Kaylaan, LLC | Drugs | 03/01/2024 | Lack of quality control unit |
| Kaylaan, LLC | Drugs | 03/01/2024 | Training , Education , Experience overall |
| Kaylaan, LLC | Drugs | 03/01/2024 | Buildings not maintained in good state of repair |
| Kaylaan, LLC | Drugs | 03/01/2024 | Equipment Design, Size and Location |
| Kaylaan, LLC | Drugs | 03/01/2024 | Written procedures not established/followed |
| Kaylaan, LLC | Drugs | 03/01/2024 | Component identity verification |
| Kaylaan, LLC | Drugs | 03/01/2024 | Absence of Written Procedures |
| Kaylaan, LLC | Drugs | 03/01/2024 | Verification of component addition |
| Kaylaan, LLC | Drugs | 03/01/2024 | Testing and release for distribution |
| Kaylaan, LLC | Drugs | 03/01/2024 | Adequate number of batches on stability |
| Kaylaan, LLC | Drugs | 03/01/2024 | Review of representative number of batches |
| Kaylaan, LLC | Drugs | 03/01/2024 | Batch production and Batch Control Record Requirements |
| Kaylaan, LLC | Drugs | 03/01/2024 | Investigations of discrepancies, failures |
| Long Island Jewish Medical Center | Biologics | 03/15/2024 | Establish, maintain and follow manufacturing SOPs |
| Long Island Jewish Medical Center | Biologics | 03/15/2024 | Person performing, test results, interpretation |
| Long Island Jewish Medical Center | Biologics | 03/15/2024 | Required records |
| Long Island Technology Group, LLC | Devices | 01/26/2024 | Documentation |
| New York Cryo | Biologics | 03/21/2024 | Determination based on screening and testing |
| Northern Food I/E, Inc. | Food and Cosmetics | 05/08/2024 | Personnel |
| Northern Food I/E, Inc. | Food and Cosmetics | 05/08/2024 | Sanitary operations – Plant maintenance |
| Northern Food I/E, Inc. | Food and Cosmetics | 05/08/2024 | Pest control |
| Northern Food I/E, Inc. | Food and Cosmetics | 05/08/2024 | Sanitation of food-contact surfaces – Frequency |
| Northern Food I/E, Inc. | Food and Cosmetics | 05/08/2024 | Manufacturing, processing, packing, holding – Controls |
| RD America, LLC | Food and Cosmetics | 01/22/2024 | HACCP plan implementation |
| RD America, LLC | Food and Cosmetics | 01/22/2024 | Monitoring – adequacy |
| RD America, LLC | Food and Cosmetics | 01/22/2024 | Corrective action per predetermined plan |
| Zomick’s Food Products, Ltd. | Food and Cosmetics | 03/19/2024 | Personnel |
| Zomick’s Food Products, Ltd. | Food and Cosmetics | 03/19/2024 | Sanitary operations – Plant maintenance |
| Zomick’s Food Products, Ltd. | Food and Cosmetics | 03/19/2024 | Sanitary operations – Plant sanitation |
| Zomick’s Food Products, Ltd. | Food and Cosmetics | 03/19/2024 | Pest control |
| Zomick’s Food Products, Ltd. | Food and Cosmetics | 03/19/2024 | Equipment and utensils – Design and maintenance |
| Zomick’s Food Products, Ltd. | Food and Cosmetics | 03/19/2024 | Manufacturing, processing, packing, holding – Controls |
