Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 58.5% decrease from the number of companies cited in the previous quarter.
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. The second most common type of company cited in the time period worked in the .
Of the companies cited, 20 should take voluntary actions to correct their managing operations (90.9%).
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 |
---|---|---|---|
99 Cents Only Stores, LLC | Food and Cosmetics | 01/29/2024 | Develop FSVP |
99 Cents Only Stores, LLC | Food and Cosmetics | 01/29/2024 | Document review entity's hazard analysis |
99 Cents Only Stores, LLC | Food and Cosmetics | 01/29/2024 | Evaluation - performance, risk |
99 Cents Only Stores, LLC | Food and Cosmetics | 01/29/2024 | Approved supplier procedures - importer established |
99 Cents Only Stores, LLC | Food and Cosmetics | 01/29/2024 | Supplier verification - establish written procedures |
Adolfo Ponce | Food and Cosmetics | 03/14/2024 | Supplier approval - document |
Adolfo Ponce | Food and Cosmetics | 03/14/2024 | Approved supplier procedures - importer established |
Adolfo Ponce | Food and Cosmetics | 03/14/2024 | Record - translate to English |
Amrex Zetron, Inc. | Devices | 02/08/2024 | Label to bear a unique device identifier |
Amrex Zetron, Inc. | Devices | 02/08/2024 | Quality audits - Lack of or inadequate procedures |
Amrex Zetron, Inc. | Devices | 02/08/2024 | DHR content |
Amrex Zetron, Inc. | Devices | 02/08/2024 | Service reports/MDRs/complaints |
Amrex Zetron, Inc. | Devices | 02/08/2024 | Devices subject to device identification GUDID data submission requirements. |
Chin Jung Corporation | Food and Cosmetics | 02/16/2024 | No HACCP plan |
Chin Jung Corporation | Food and Cosmetics | 02/16/2024 | HACCP training or qualification |
Chin Jung Corporation | Food and Cosmetics | 02/16/2024 | Sanitation monitoring |
Cosmos Food Company, Inc. | Food and Cosmetics | 03/27/2024 | Allergen preventive controls - Implement |
Dental Evolutions, Inc. | Devices | 02/09/2024 | Management review - Lack of or inadequate procedures |
Dental Evolutions, Inc. | Devices | 02/09/2024 | Design transfer - Lack of or inadequate procedures |
Dental Evolutions, Inc. | Devices | 02/09/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
GMS International Foods, Inc. | Food and Cosmetics | 03/20/2024 | Pest control |
Green Planet Traders, Inc. | Food and Cosmetics | 03/20/2024 | Develop FSVP |
Green Planet Traders, Inc. | Food and Cosmetics | 03/20/2024 | Evaluation - performance, risk |
Green Planet Traders, Inc. | Food and Cosmetics | 03/20/2024 | Audit - food safety regulation, plan |
Heritage International USA, Inc. | Food and Cosmetics | 02/02/2024 | Personnel |
Heritage International USA, Inc. | Food and Cosmetics | 02/02/2024 | Sanitary operations - Plant maintenance |
Heritage International USA, Inc. | Food and Cosmetics | 02/02/2024 | Equipment and utensils - Design and maintenance |
Heritage International USA, Inc. | Food and Cosmetics | 02/02/2024 | Process control - Foreign objects |
IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Personnel |
IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Sanitary operations - Plant sanitation |
IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Pest control |
IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Sanitation of food-contact surfaces - Frequency |
IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Equipment and utensils - Design and maintenance |
IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Plant operations - Precautions |
IFOOD Food Company | Food and Cosmetics | 03/21/2024 | Storage and Distribution |
JH corporation | Food and Cosmetics | 03/21/2024 | Develop FSVP |
Kashmir Snacks International, Inc. | Food and Cosmetics | 01/19/2024 | Grounds |
Kashmir Snacks International, Inc. | Food and Cosmetics | 01/19/2024 | Pest control |
Kashmir Snacks International, Inc. | Food and Cosmetics | 01/19/2024 | Storage and Distribution |
Organic and sustainable Beauty, Inc. | Drugs | 03/13/2024 | Procedures not in writing, fully followed |
Organic and sustainable Beauty, Inc. | Drugs | 03/13/2024 | Cleaning / Sanitizing / Maintenance |
Organic and sustainable Beauty, Inc. | Drugs | 03/13/2024 | Cleaning SOPs/instructions |
Organic and sustainable Beauty, Inc. | Drugs | 03/13/2024 | Items to cover on annual reviews |
Organic and sustainable Beauty, Inc. | Drugs | 03/13/2024 | Procedures to be written and followed |
P & D Seafood Company | Food and Cosmetics | 02/02/2024 | HACCP plan implementation |
P & D Seafood Company | Food and Cosmetics | 02/02/2024 | Verification - reviewers qualifications |
Pdla, Inc. | Food and Cosmetics | 02/28/2024 | Hazard analysis written |
Pdla, Inc. | Food and Cosmetics | 02/28/2024 | Evaluation - performance, risk |
Pdla, Inc. | Food and Cosmetics | 02/28/2024 | Verification activity - appropriate |
Peymamn Saadat Inc., M.D. | Biologics | 02/20/2024 | Statement re: certified testing lab |
Peymamn Saadat Inc., M.D. | Biologics | 02/20/2024 | Improperly released for distribution |
Rehan Spices, Inc. | Food and Cosmetics | 02/27/2024 | Develop FSVP |
Rehan Spices, Inc. | Food and Cosmetics | 02/27/2024 | Hazard analysis written |
Rehan Spices, Inc. | Food and Cosmetics | 02/27/2024 | Document review entity's hazard analysis |
Rehan Spices, Inc. | Food and Cosmetics | 02/27/2024 | Evaluation - performance, risk |
Rehan Spices, Inc. | Food and Cosmetics | 02/27/2024 | Supplier approval - document |
Rehan Spices, Inc. | Food and Cosmetics | 02/27/2024 | Verification activity assurance |
Seoul Trading, Inc. | Food and Cosmetics | 03/13/2024 | Hazard analysis biological, chemical, physical |
Seoul Trading, Inc. | Food and Cosmetics | 03/13/2024 | Evaluation - performance, risk |
Seoul Trading, Inc. | Food and Cosmetics | 03/13/2024 | Audit - food safety regulation, plan |
The Choice Produce, Inc. | Food and Cosmetics | 01/29/2024 | Develop FSVP |
Tijuana'S Produce, Inc. | Food and Cosmetics | 02/22/2024 | Develop FSVP |
Tijuana'S Produce, Inc. | Food and Cosmetics | 02/22/2024 | Audit - food safety regulation, plan |
YOU & Song, Company, Inc. | Food and Cosmetics | 02/13/2024 | Personnel |
YOU & Song, Company, Inc. | Food and Cosmetics | 02/13/2024 | Grounds |
YOU & Song, Company, Inc. | Food and Cosmetics | 02/13/2024 | Sanitary operations - Plant maintenance |
YOU & Song, Company, Inc. | Food and Cosmetics | 02/13/2024 | Toxic chemicals - Identified, held, stored |
YOU & Song, Company, Inc. | Food and Cosmetics | 02/13/2024 | Pest control |
YOU & Song, Company, Inc. | Food and Cosmetics | 02/13/2024 | Sanitation of food-contact surfaces - Frequency |
YOU & Song, Company, Inc. | Food and Cosmetics | 02/13/2024 | Sanitation of non-food-contact surfaces - Manner and frequency |
YOU & Song, Company, Inc. | Food and Cosmetics | 02/13/2024 | Equipment and utensils - Design and maintenance |
YOU & Song, Company, Inc. | Food and Cosmetics | 02/13/2024 | Manufacturing, processing, packing, holding - Controls |
Yamasa Enterprises, Inc. | Food and Cosmetics | 02/12/2024 | HACCP plan implementation |
Yamasa Enterprises, Inc. | Food and Cosmetics | 02/12/2024 | Food safety hazards |
Yamasa Enterprises, Inc. | Food and Cosmetics | 02/12/2024 | Corrective action per predetermined plan |
Yamasa Enterprises, Inc. | Food and Cosmetics | 02/12/2024 | Verification - record review - frequency |
Yamasa Enterprises, Inc. | Food and Cosmetics | 02/12/2024 | Sanitation monitoring documentation |