There were seven companies in cities associated with Richmond County that received FDA citations as a result of seven inspections conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 16.7% increase over the number of companies cited in the previous quarter.
Of the 25 citations issued, the most common citation was ‘You did not have records documenting food hygiene and food safety training’.
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 |
| 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 |
| Joe Mozz, Inc. | Food and Cosmetics | 02/08/2024 | Qualifications of individuals |
| Joe Mozz, Inc. | Food and Cosmetics | 02/08/2024 | Sanitary operations – Plant sanitation |
| Joe Mozz, Inc. | Food and Cosmetics | 02/08/2024 | Manufacturing, processing, packing, holding – Controls |
| 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 |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Qualifications of individuals |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Personnel |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Plant construction and design |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Pest control |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Sanitary facilities and controls |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Hazard analysis – Identification of hazard |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Allergen preventive controls – Implement |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Process preventive controls – Implement |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Sanitation preventive controls – Implement |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Sanitation preventive controls – Appropriate (Adequate) |
| Port Richmond Bakery Corporation | Food and Cosmetics | 03/28/2024 | Supply-chain program – Implement |
