James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is unchanged from the number of companies inspected in the previous quarter.
Most of the companies inspected at the time were involved in the Biologics sector. The second most common type of company inspected worked in the Food and Cosmetics sector.
There were 11 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (64.7%). Six should take voluntary action to correct their management operations (35.3%).
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 | Result |
|---|---|---|---|
| Billybey Marina Services, LLC | Food and Cosmetics | 01/23/2024 | Voluntary Action Indicated (VAI) |
| DiscCath, LLC | Devices | 01/04/2024 | No Action Indicated (NAI) |
| Dr. Prakash Krishnan | Devices | 02/29/2024 | No Action Indicated (NAI) |
| Ferny | Biologics | 02/12/2024 | No Action Indicated (NAI) |
| Generation Next Fertility | Biologics | 01/12/2024 | Voluntary Action Indicated (VAI) |
| Helena A. Yu, M.D. | Drugs | 01/16/2024 | No Action Indicated (NAI) |
| J&H Imports Services Corporation | Food and Cosmetics | 01/29/2024 | Voluntary Action Indicated (VAI) |
| Joe Mozz, Inc. | Food and Cosmetics | 02/08/2024 | Voluntary Action Indicated (VAI) |
| NYC Health + Hospitals/Bellevue | Biologics | 03/28/2024 | No Action Indicated (NAI) |
| NYC In Vitro Fertilization, P.C. | Biologics | 02/27/2024 | No Action Indicated (NAI) |
| Neurodynamics, Inc. | Devices | 02/28/2024 | Voluntary Action Indicated (VAI) |
| New Hope Fertility Center | Biologics | 02/22/2024 | Voluntary Action Indicated (VAI) |
| Northwell Health Fertility NYC | Biologics | 03/19/2024 | No Action Indicated (NAI) |
| Oatly, Inc. | Food and Cosmetics | 01/17/2024 | No Action Indicated (NAI) |
| Reinauer Transportation Companies, LLC | Food and Cosmetics | 02/27/2024 | No Action Indicated (NAI) |
| Reproductive Medicine Associates of New York, LLP | Biologics | 01/31/2024 | No Action Indicated (NAI) |
| Rona D. Yaeger, M.D. | Drugs | 03/12/2024 | No Action Indicated (NAI) |
Alerts Sign-up