Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 266.7% increase over the number of companies cited in the previous month.
Of the 44 citations issued, the most common citations include:
- You did not have a written hazard analysis.
- You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
- You did not take a reasonable measure or precaution related to personnel practices.
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, 10 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.
Companies located within Los Angeles County Cities and the citations they received in February
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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