Western Wayne Today

There were 13 companies in cities associated with Wayne County that received FDA citations as a result of 13 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 43.5% decrease from the number of companies cited in the previous year.

Of the 47 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, 10 should take voluntary actions to correct their managing operations (76.9%). Additionally, one company had to take regulatory and/or administrative actions (7.7%).

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
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
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
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