There were 16 companies in cities associated with Wayne County that received FDA citations as a result of 16 inspections conducted in the county in 2024, according to the U.S. Food and Drug Administration (FDA).
This is a 36% decrease from the number of companies cited in the previous year.
Of the 54 citations issued, the most common citation was ‘Your hazard analysis did not identify a hazard that required a preventive control’.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, 12 should take voluntary actions to correct their managing operations (75%). Additionally, two companies had to take regulatory and/or administrative actions (12.5%).
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 and quality.
Companies Located within Wayne County Cities and the Citations They Received in 2024
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Alsaeedah Grocery & Spice, LLC. | Food and Cosmetics | 09/13/2024 | Develop FSVP |
| DO & Company Detroit, Inc. | Food and Cosmetics | 11/15/2024 | Hazard analysis – Identification of hazard |
| DO & Company Detroit, Inc. | Food and Cosmetics | 11/15/2024 | Process preventive controls – Appropriate (Adequate) |
| DO & Company Detroit, Inc. | Food and Cosmetics | 11/15/2024 | Sanitation preventive controls – Appropriate (Adequate) |
| DO & Company Detroit, Inc. | Food and Cosmetics | 11/15/2024 | Supply-chain program – Implement |
| DO & Company Detroit, Inc. | Food and Cosmetics | 11/15/2024 | All hazards not considered |
| DO & Company Detroit, Inc. | Food and Cosmetics | 11/15/2024 | Process controls – HACCP plan – 5 log reduction |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Personnel – hygienic practices |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Plumbing – source of contamination |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Plumbing – floor drainage |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Hand-washing facilities |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Physical plant – separate areas – cleaning, sanitizing |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Equipment – maintain – general |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Equipment – automated – calibrate, inspect |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Specifications – component identity |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Specifications-component purity, strength, composition |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Specifications – identity, purity, strength, composition |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Batch record – complete |
| Enrinity Supplements, Inc. | Food and Cosmetics | 04/22/2024 | Batch record – results; monitoring |
| Fiesta Gourmet & Deli, Inc. | Food and Cosmetics | 07/05/2024 | Personnel |
| Fiesta Gourmet & Deli, Inc. | Food and Cosmetics | 07/05/2024 | Cleaning and sanitizing substances – Safe and adequate |
| Fiesta Gourmet & Deli, Inc. | Food and Cosmetics | 07/05/2024 | Manufacturing, processing, packing, holding – Controls |
| Food Entrepreneur Accelerator and Startup Terminal | Food and Cosmetics | 12/18/2024 | Personnel |
| Food Entrepreneur Accelerator and Startup Terminal | Food and Cosmetics | 12/18/2024 | Sanitary operations – Plant sanitation |
| Great Lakes Food Center, LLC | Food and Cosmetics | 06/05/2024 | Sanitation preventive controls – Implement |
| Great Lakes Food Center, LLC | Food and Cosmetics | 06/05/2024 | Process preventive controls – Implementation records |
| Joe Randazzo’s Fruit & Vegetable, Inc. | Food and Cosmetics | 05/14/2024 | Manufacturing, processing, packing, holding – Controls |
| Jogue, Inc. | Food and Cosmetics | 01/30/2024 | Sanitary operations – Plant maintenance |
| La Michoacana, Inc. | Food and Cosmetics | 03/22/2024 | Sanitary operations – Plant sanitation |
| La Michoacana, Inc. | Food and Cosmetics | 03/22/2024 | Pest control |
| La Michoacana, Inc. | Food and Cosmetics | 03/22/2024 | Equipment and utensils – Design and maintenance |
| La Michoacana, Inc. | Food and Cosmetics | 03/22/2024 | Hazard analysis – Identification of hazard |
| La Michoacana, Inc. | Food and Cosmetics | 03/22/2024 | Process preventive controls – Appropriate (Adequate) |
| La Michoacana, Inc. | Food and Cosmetics | 03/22/2024 | Supply-chain program – Establish |
| Leonard Fountain Specialties, Inc. | Food and Cosmetics | 03/15/2024 | Hazard analysis – Identification of hazard |
| Leonard Fountain Specialties, Inc. | Food and Cosmetics | 03/15/2024 | Hazard analysis – written – elements |
| Leonard Fountain Specialties, Inc. | Food and Cosmetics | 03/15/2024 | Records required – not maintained |
| NUTCO, Inc. | Food and Cosmetics | 05/09/2024 | Sanitation of non-food-contact surfaces – Manner and frequency |
| NUTCO, Inc. | Food and Cosmetics | 05/09/2024 | Hazard analysis – Identification of hazard |
| NUTCO, Inc. | Food and Cosmetics | 05/09/2024 | Sanitation preventive controls – Appropriate (Adequate) |
| NUTCO, Inc. | Food and Cosmetics | 05/09/2024 | Supply-chain program – Assurance (Adequate) |
| Riggio Distribution Company | Food and Cosmetics | 05/06/2024 | Develop FSVP |
| Shirish M. Gadgeel, M.D. | Drugs | 08/23/2024 | FD-1572, protocol compliance |
| Shirish M. Gadgeel, M.D. | Drugs | 08/23/2024 | Informed consent |
| Shirish M. Gadgeel, M.D. | Drugs | 08/23/2024 | Case history records- inadequate or inadequate |
| Shirish M. Gadgeel, M.D. | Drugs | 08/23/2024 | Safety Reports – Serious Events |
| Synchronis Medical, LLC | Devices | 06/04/2024 | Nonconforming product, Lack of or inadequate procedures |
| Synchronis Medical, LLC | Devices | 06/04/2024 | GUDID Information required for unique device identification. |
| U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/17/2024 | Develop FSVP |
| U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/17/2024 | Hazard analysis biological, chemical, physical |
| U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/17/2024 | Document review entity’s hazard analysis |
| U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/17/2024 | Evaluation – performance, risk |
| U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/17/2024 | Verification activity – appropriate |
| Yasmeen Pita, LLC | Food and Cosmetics | 02/20/2024 | Sanitary operations – Plant maintenance |
