Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 19% increase over the number of companies inspected in the previous quarter, when 21 companies received 21 inspections.
Most of the companies inspected at the time were involved in the Devices and Food and Cosmetics sectors. The second most common type of company inspected worked in the Biologics sector.
There were 13 companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (52%). 12 should take voluntary action to correct their management operations (48%).
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 |
|---|---|---|---|
| Cambridge Diagnostic Products, Inc. | Devices | 03/16/2023 | Voluntary Action Indicated (VAI) |
| Classical Insights, LLC | Food and Cosmetics | 01/24/2023 | Voluntary Action Indicated (VAI) |
| Don Julio Fresh, LLC | Food and Cosmetics | 03/30/2023 | No Action Indicated (NAI) |
| ECI Pharmaceuticals, LLC | Drugs | 01/27/2023 | Voluntary Action Indicated (VAI) |
| First World Imports, Inc. | Food and Cosmetics | 03/28/2023 | Voluntary Action Indicated (VAI) |
| GA Food Service of Pinellas County, LLC. | Food and Cosmetics | 02/13/2023 | Voluntary Action Indicated (VAI) |
| GTO Import Export, LLC | Food and Cosmetics | 03/01/2023 | Voluntary Action Indicated (VAI) |
| Groman, Inc. | Devices | 03/07/2023 | No Action Indicated (NAI) |
| Health Genesis Corporation | Food and Cosmetics | 02/24/2023 | Voluntary Action Indicated (VAI) |
| Hospitality Purchasing, LLC | Food and Cosmetics | 02/09/2023 | No Action Indicated (NAI) |
| IVF Florida Reproductive Associates | Biologics | 02/03/2023 | No Action Indicated (NAI) |
| InnoMed Healthscience, Inc. | Devices | 01/11/2023 | No Action Indicated (NAI) |
| Memorial Regional Hospital | Biologics | 02/08/2023 | No Action Indicated (NAI) |
| Narang Medical USA Corporation | Devices | 03/17/2023 | No Action Indicated (NAI) |
| New Wave Endo-Surgical, Corp. | Devices | 02/17/2023 | Voluntary Action Indicated (VAI) |
| North Broward Hospital District IRB | Biologics | 02/02/2023 | No Action Indicated (NAI) |
| North Broward Hospital District IRB | Devices | 02/02/2023 | No Action Indicated (NAI) |
| North Broward Hospital District IRB | Drugs | 02/02/2023 | No Action Indicated (NAI) |
| Nutek Orthopaedics, Inc. | Devices | 03/09/2023 | No Action Indicated (NAI) |
| Octapharma Plasma, Inc. | Biologics | 03/16/2023 | No Action Indicated (NAI) |
| One Stop Distribution, LLC | Food and Cosmetics | 02/24/2023 | No Action Indicated (NAI) |
| Peter P. Ventre, M.D. | Drugs | 01/18/2023 | Voluntary Action Indicated (VAI) |
| Petnet Solutions, Inc. | Drugs | 01/20/2023 | Voluntary Action Indicated (VAI) |
| Scott H. Schecter, O.D. | Drugs | 02/06/2023 | Voluntary Action Indicated (VAI) |
| Slater Endoscopy, LLC | Devices | 02/02/2023 | Voluntary Action Indicated (VAI) |
| South Broward Hospital District | Biologics | 03/29/2023 | No Action Indicated (NAI) |
| South Florida Institute for Reproductive Medicine/IVFMD | Biologics | 02/07/2023 | No Action Indicated (NAI) |
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