Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 40% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- You did not maintain your plant in adequate repair.
- You did not establish and maintain procedures for screening and determining the eligibility of HCT/P donors.
- The eligibility of an HCT/P donor was not determined by a responsible person, based on results of donor screening and donor testing.
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 |
| Brooklyn Brands, LLC | Food and Cosmetics | 03/28/2024 | Sanitary operations - Plant maintenance |
| 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 |
| 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 |
| 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 |
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