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Thursday, October 31, 2024

How many companies in cities across Wayne County received FDA citations in 2023?

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Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website

There were 23 companies in cities associated with Wayne County that received FDA citations as a result of 24 inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 91.7% increase over the number of companies cited in the previous year.

Of the 77 citations issued, the most common citation was 'You did not develop an FSVP'.

Most of the companies cited were involved in the Food and Cosmetics sector.

Of the companies cited, 21 should take voluntary actions to correct their managing operations (91.3%). Additionally, three companies had to take regulatory and/or administrative actions (13%).

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.

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, according to its website.

Companies Located Within Wayne County Cities and the Citations They Received in 2023
Company NameArea of BusinessInspection DateIssue Cited
ARYZ Trading, LLCFood and Cosmetics08/08/2023Develop FSVP
AVFLight, Inc.Food and Cosmetics07/19/2023Prevention of contamination
AVFLight, Inc.Food and Cosmetics07/19/2023Backflow prevention - general
Altayeb Import and Export, Inc.Food and Cosmetics05/02/2023Develop FSVP
Altayeb Import and Export, Inc.Food and Cosmetics05/02/2023Identification - entry
Altayeb Import and Export, Inc.Food and Cosmetics12/22/2023Very small importer assurances, supplier
Bhullar Imports USA, LLCFood and Cosmetics06/23/2023Develop FSVP
DO & Company Detroit, Inc.Food and Cosmetics12/15/2023Sanitation preventive controls - Appropriate (Adequate)
Diamonds Trading Company, LLCFood and Cosmetics03/27/2023Develop FSVP
Dipenkumar Modi, M.D.Drugs04/12/2023FD-1572, protocol compliance
Dipenkumar Modi, M.D.Drugs04/12/2023Unanticipated problems
Emesa Foods Company, LLCFood and Cosmetics01/09/2023Very small importer assurances, supplier
Fresh Pak, Inc.Food and Cosmetics08/04/2023Sanitary operations - Plant maintenance
Fresh Pak, Inc.Food and Cosmetics08/04/2023Manufacturing, processing, packing, holding - Controls
G & A Baking Company, L.L.C.Food and Cosmetics06/02/2023Sanitary operations - Plant maintenance
G & A Baking Company, L.L.C.Food and Cosmetics06/02/2023Raw materials - Allergen identification
G & A Baking Company, L.L.C.Food and Cosmetics06/02/2023Manufacturing, processing, packing, holding - Controls
G & A Baking Company, L.L.C.Food and Cosmetics06/02/2023Storage and Distribution
Hacienda Mexican FoodsFood and Cosmetics04/21/2023Sanitary operations - Plant maintenance
Hacienda Mexican FoodsFood and Cosmetics04/21/2023Pest control
Hacienda Mexican FoodsFood and Cosmetics04/21/2023Hazard analysis - Identification of hazard
Hacienda Mexican FoodsFood and Cosmetics04/21/2023Allergen preventive controls - Identify (Written)
Hacienda Mexican FoodsFood and Cosmetics04/21/2023Process preventive controls - Identify (Written)
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Equipment - maintain - general
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Cleaning compounds - adequate, safe
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Quality control - quality, dietary supplement
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Specifications - component identity
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Specifications - labels, packaging
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Specifications - identity, purity, strength, composition
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Master manufacturing record - each batch
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Batch record - complete
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Written procedures - laboratory operations
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Batch-lot,control number packaged, labeled dietary supplemen
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Written procedures - holding
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Written procedures - returned dietary supplement
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc.Food and Cosmetics03/16/2023Written procedures - product complaint
Motor City Seafood CompanyFood and Cosmetics02/03/2023Monitoring - none
Motor City Seafood CompanyFood and Cosmetics02/03/2023Monitoring - adequacy
Motor City Seafood CompanyFood and Cosmetics02/03/2023Corrective action per regulation
Motor City Seafood CompanyFood and Cosmetics02/03/2023Sanitation monitoring
Nikis Food Company, Inc.Food and Cosmetics04/26/2023Process filing
Nikis Food Company, Inc.Food and Cosmetics04/26/2023Recall procedures
Nikis Food Company, Inc.Food and Cosmetics04/26/2023Quality control procedures
Nikis Food Company, Inc.Food and Cosmetics04/26/2023Sanitary operations - Plant maintenance
Nikis Food Company, Inc.Food and Cosmetics04/26/2023Appropriate quality control operations
Patel BrosFood and Cosmetics12/27/2023Develop FSVP
Rich Products CorporationFood and Cosmetics11/28/2023Sanitary operations - Plant maintenance
Rich Products CorporationFood and Cosmetics11/28/2023Sanitation preventive controls - Implement
Rich Products CorporationFood and Cosmetics11/28/2023Sanitation preventive controls - Appropriate (Adequate)
Samra' a' Aden, LLCFood and Cosmetics01/23/2023Develop FSVP
Snf Holdings, LLCDrugs03/02/2023Hazardous drugs, prevention of cross-contamination
Snf Holdings, LLCDrugs03/02/2023Non-microbial contamination, production area
Snf Holdings, LLCDrugs03/02/2023Use of non-pharmaceutical grade components
T N FoodsFood and Cosmetics06/13/2023Develop FSVP
U. B. C. Food Distributors, Inc.Food and Cosmetics06/07/2023Hazard analysis biological, chemical, physical
U. B. C. Food Distributors, Inc.Food and Cosmetics06/07/2023Supplier approval - document
U. B. C. Food Distributors, Inc.Food and Cosmetics06/07/2023Reevaluate - 3 years
U. B. C. Food Distributors, Inc.Food and Cosmetics06/07/2023Approved supplier procedures - follow, document use
U. B. C. Food Distributors, Inc.Food and Cosmetics06/07/2023Verification activity frequency
U. B. C. Food Distributors, Inc.Food and Cosmetics06/07/2023Onsite audit
U. B. C. Food Distributors, Inc.Food and Cosmetics06/07/2023Verification activity before import, periodically
VitaNorth USA, LLCFood and Cosmetics02/22/2023Personnel - hygienic practices
VitaNorth USA, LLCFood and Cosmetics02/22/2023Specifications - component identity
VitaNorth USA, LLCFood and Cosmetics02/22/2023Specifications - identity, purity, strength, composition
VitaNorth USA, LLCFood and Cosmetics02/22/2023Re-confirm certificate of analysis
VitaNorth USA, LLCFood and Cosmetics02/22/2023Specifications met - verify; finished batch
VitaNorth USA, LLCFood and Cosmetics02/22/2023Specifications not met - identity; component, reject
VitaNorth USA, LLCFood and Cosmetics02/22/2023Quality control - components; tests, examination results
VitaNorth USA, LLCFood and Cosmetics02/22/2023Master manufacturing record - each batch
VitaNorth USA, LLCFood and Cosmetics02/22/2023Hold - adversely affected
VitaNorth USA, LLCFood and Cosmetics02/22/2023Hold - mix-up, contamination, deterioration
VitaNorth USA, LLCFood and Cosmetics02/22/2023Hold, identify - in-process material
Wayne County Airport AuthorityFood and Cosmetics09/15/2023Prevention of contamination
Wayne County Airport AuthorityFood and Cosmetics09/15/2023Equipment for cleaning and flushing
Weyand Fisheries, Inc.Food and Cosmetics06/08/2023HACCP plan implementation
Weyand Fisheries, Inc.Food and Cosmetics06/08/2023Food safety hazards
Weyand Fisheries, Inc.Food and Cosmetics06/08/2023Sanitation monitoring

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