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
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.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
ARYZ Trading, LLC | Food and Cosmetics | 08/08/2023 | Develop FSVP |
AVFLight, Inc. | Food and Cosmetics | 07/19/2023 | Prevention of contamination |
AVFLight, Inc. | Food and Cosmetics | 07/19/2023 | Backflow prevention - general |
Altayeb Import and Export, Inc. | Food and Cosmetics | 05/02/2023 | Develop FSVP |
Altayeb Import and Export, Inc. | Food and Cosmetics | 05/02/2023 | Identification - entry |
Altayeb Import and Export, Inc. | Food and Cosmetics | 12/22/2023 | Very small importer assurances, supplier |
Bhullar Imports USA, LLC | Food and Cosmetics | 06/23/2023 | Develop FSVP |
DO & Company Detroit, Inc. | Food and Cosmetics | 12/15/2023 | Sanitation preventive controls - Appropriate (Adequate) |
Diamonds Trading Company, LLC | Food and Cosmetics | 03/27/2023 | Develop FSVP |
Dipenkumar Modi, M.D. | Drugs | 04/12/2023 | FD-1572, protocol compliance |
Dipenkumar Modi, M.D. | Drugs | 04/12/2023 | Unanticipated problems |
Emesa Foods Company, LLC | Food and Cosmetics | 01/09/2023 | Very small importer assurances, supplier |
Fresh Pak, Inc. | Food and Cosmetics | 08/04/2023 | Sanitary operations - Plant maintenance |
Fresh Pak, Inc. | Food and Cosmetics | 08/04/2023 | Manufacturing, processing, packing, holding - Controls |
G & A Baking Company, L.L.C. | Food and Cosmetics | 06/02/2023 | Sanitary operations - Plant maintenance |
G & A Baking Company, L.L.C. | Food and Cosmetics | 06/02/2023 | Raw materials - Allergen identification |
G & A Baking Company, L.L.C. | Food and Cosmetics | 06/02/2023 | Manufacturing, processing, packing, holding - Controls |
G & A Baking Company, L.L.C. | Food and Cosmetics | 06/02/2023 | Storage and Distribution |
Hacienda Mexican Foods | Food and Cosmetics | 04/21/2023 | Sanitary operations - Plant maintenance |
Hacienda Mexican Foods | Food and Cosmetics | 04/21/2023 | Pest control |
Hacienda Mexican Foods | Food and Cosmetics | 04/21/2023 | Hazard analysis - Identification of hazard |
Hacienda Mexican Foods | Food and Cosmetics | 04/21/2023 | Allergen preventive controls - Identify (Written) |
Hacienda Mexican Foods | Food and Cosmetics | 04/21/2023 | Process preventive controls - Identify (Written) |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Equipment - maintain - general |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Cleaning compounds - adequate, safe |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Quality control - quality, dietary supplement |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Specifications - component identity |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Specifications - labels, packaging |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Specifications - identity, purity, strength, composition |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Master manufacturing record - each batch |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Batch record - complete |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Written procedures - laboratory operations |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Batch-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 Cosmetics | 03/16/2023 | Written procedures - holding |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Written procedures - returned dietary supplement |
Moorish Science Temple The Divine and National Movement of North America; #13 The Moorish American National Republic, Inc. | Food and Cosmetics | 03/16/2023 | Written procedures - product complaint |
Motor City Seafood Company | Food and Cosmetics | 02/03/2023 | Monitoring - none |
Motor City Seafood Company | Food and Cosmetics | 02/03/2023 | Monitoring - adequacy |
Motor City Seafood Company | Food and Cosmetics | 02/03/2023 | Corrective action per regulation |
Motor City Seafood Company | Food and Cosmetics | 02/03/2023 | Sanitation monitoring |
Nikis Food Company, Inc. | Food and Cosmetics | 04/26/2023 | Process filing |
Nikis Food Company, Inc. | Food and Cosmetics | 04/26/2023 | Recall procedures |
Nikis Food Company, Inc. | Food and Cosmetics | 04/26/2023 | Quality control procedures |
Nikis Food Company, Inc. | Food and Cosmetics | 04/26/2023 | Sanitary operations - Plant maintenance |
Nikis Food Company, Inc. | Food and Cosmetics | 04/26/2023 | Appropriate quality control operations |
Patel Bros | Food and Cosmetics | 12/27/2023 | Develop FSVP |
Rich Products Corporation | Food and Cosmetics | 11/28/2023 | Sanitary operations - Plant maintenance |
Rich Products Corporation | Food and Cosmetics | 11/28/2023 | Sanitation preventive controls - Implement |
Rich Products Corporation | Food and Cosmetics | 11/28/2023 | Sanitation preventive controls - Appropriate (Adequate) |
Samra' a' Aden, LLC | Food and Cosmetics | 01/23/2023 | Develop FSVP |
Snf Holdings, LLC | Drugs | 03/02/2023 | Hazardous drugs, prevention of cross-contamination |
Snf Holdings, LLC | Drugs | 03/02/2023 | Non-microbial contamination, production area |
Snf Holdings, LLC | Drugs | 03/02/2023 | Use of non-pharmaceutical grade components |
T N Foods | Food and Cosmetics | 06/13/2023 | Develop FSVP |
U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/07/2023 | Hazard analysis biological, chemical, physical |
U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/07/2023 | Supplier approval - document |
U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/07/2023 | Reevaluate - 3 years |
U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/07/2023 | Approved supplier procedures - follow, document use |
U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/07/2023 | Verification activity frequency |
U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/07/2023 | Onsite audit |
U. B. C. Food Distributors, Inc. | Food and Cosmetics | 06/07/2023 | Verification activity before import, periodically |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Personnel - hygienic practices |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Specifications - component identity |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Specifications - identity, purity, strength, composition |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Re-confirm certificate of analysis |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Specifications met - verify; finished batch |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Specifications not met - identity; component, reject |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Quality control - components; tests, examination results |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Master manufacturing record - each batch |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Hold - adversely affected |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Hold - mix-up, contamination, deterioration |
VitaNorth USA, LLC | Food and Cosmetics | 02/22/2023 | Hold, identify - in-process material |
Wayne County Airport Authority | Food and Cosmetics | 09/15/2023 | Prevention of contamination |
Wayne County Airport Authority | Food and Cosmetics | 09/15/2023 | Equipment for cleaning and flushing |
Weyand Fisheries, Inc. | Food and Cosmetics | 06/08/2023 | HACCP plan implementation |
Weyand Fisheries, Inc. | Food and Cosmetics | 06/08/2023 | Food safety hazards |
Weyand Fisheries, Inc. | Food and Cosmetics | 06/08/2023 | Sanitation monitoring |