Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is a 100% increase over the number of companies inspected in the previous year, when two companies were inspected through two inspections.
Most of the companies inspected were involved in the Drugs sector. The second most common type of company inspected in the time period worked in the Biologics sector.
There were two companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct the organization's management operations. Additionally, one company had to take regulatory and/or administrative actions.
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 |
---|---|---|---|
Baxter Pharmaceutical Solutions, LLC | Drugs | 02/17/2023 | No Action Indicated (NAI) |
BioLife Plasma Services, L. P | Biologics | 03/16/2023 | No Action Indicated (NAI) |
Catalent Indiana, LLC | Biologics | 11/15/2023 | Voluntary Action Indicated (VAI) |
Catalent Indiana, LLC | Drugs | 11/15/2023 | Voluntary Action Indicated (VAI) |
KP Pharmaceutical Technology | Drugs | 02/03/2023 | Official Action Indicated (OAI) |