Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 7.7% increase over the number of companies cited in the previous quarter.
Of the 35 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 .
All of the companies cited should take voluntary actions to correct their managing operations.
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 |
|---|---|---|---|
| Billybey Marina Services, LLC | Food and Cosmetics | 01/23/2024 | Prevention of contamination |
| Dairy Maid Ravioli Manufacturing, Corporation | Food and Cosmetics | 01/25/2024 | Records system |
| Dairy Maid Ravioli Manufacturing, Corporation | Food and Cosmetics | 01/25/2024 | Monitoring record review adequacy |
| Fresh Goods Trading Corporation | Food and Cosmetics | 03/15/2024 | Develop FSVP |
| Generation Next Fertility | Biologics | 01/12/2024 | Design of procedures to ensure compliance |
| Generation Next Fertility | Biologics | 01/12/2024 | Accurate, indelible, legible |
| Generation Next Fertility | Biologics | 01/12/2024 | Risk factors, clinical evidence |
| Gobwa Exotic Imports, Inc. | Food and Cosmetics | 01/05/2024 | Importer verification |
| J&H Imports Services Corporation | Food and Cosmetics | 01/29/2024 | Develop FSVP |
| J&H Imports Services Corporation | Food and Cosmetics | 01/29/2024 | Hazard analysis biological, chemical, physical |
| J&H Imports Services Corporation | Food and Cosmetics | 01/29/2024 | Reevaluate - document |
| Jiro Group, Inc. | Food and Cosmetics | 01/29/2024 | Written procedures - holding; distributing |
| Jiro Group, Inc. | Food and Cosmetics | 01/29/2024 | Written procedures - returned dietary supplement |
| Mr. Pickle, Inc. | Food and Cosmetics | 01/17/2024 | Sanitary operations - Plant maintenance |
| Neurodynamics, Inc. | Devices | 02/28/2024 | Lack of Written MDR Procedures |
| New Hope Fertility Center | Biologics | 02/22/2024 | Testing, screening, donor eligibility procedures |
| New Hope Fertility Center | Biologics | 02/22/2024 | Responsible person to determine, document |
| New Hope Fertility Center | Biologics | 02/22/2024 | Eligibility not required--warning labels |
| Shata Traders, Inc. | Food and Cosmetics | 01/04/2024 | Develop FSVP |
| Twin Wings BRO, Inc. | Food and Cosmetics | 01/25/2024 | Develop FSVP |
| Vasinee Food, Corp. | Food and Cosmetics | 02/22/2024 | Develop FSVP |
| Vasinee Food, Corp. | Food and Cosmetics | 02/22/2024 | Hazard analysis written |
| Vasinee Food, Corp. | Food and Cosmetics | 02/22/2024 | Hazard analysis biological, chemical, physical |
| Vasinee Food, Corp. | Food and Cosmetics | 02/22/2024 | Document review entity's hazard analysis |
| Vasinee Food, Corp. | Food and Cosmetics | 02/22/2024 | Evaluation - performance, risk |
| Vasinee Food, Corp. | Food and Cosmetics | 02/22/2024 | Supplier verification - establish written procedures |
| Vasinee Food, Corp. | Food and Cosmetics | 02/22/2024 | Verification activity before import, periodically |
| Vasinee Food, Corp. | Food and Cosmetics | 02/22/2024 | Record - translate to English |
| World Of Chantilly, Inc. | Food and Cosmetics | 03/07/2024 | Grounds |
| World Of Chantilly, Inc. | Food and Cosmetics | 03/07/2024 | Sanitary operations - Plant maintenance |
| World Of Chantilly, Inc. | Food and Cosmetics | 03/07/2024 | Toxic chemicals - Identified, held, stored |
| World Of Chantilly, Inc. | Food and Cosmetics | 03/07/2024 | Pest control |
| World Of Chantilly, Inc. | Food and Cosmetics | 03/07/2024 | Sanitation of food-contact surfaces - Frequency |
| World Of Chantilly, Inc. | Food and Cosmetics | 03/07/2024 | Plant operations - Precautions |
| World Of Chantilly, Inc. | Food and Cosmetics | 03/07/2024 | Raw materials and rework controls - Filth and contamination |
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