Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 100% increase over the number of companies inspected in the previous quarter, when one company received one inspection.
The companies inspected were involved in either the Devices or Biologics sectors.
There was one company in line with FDA regulations that does not need to adjust their management operations or regulatory/administrative actions. One should take voluntary action to correct its management 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 | Result |
|---|---|---|---|
| Cerapedics, Inc. | Devices | 03/13/2024 | Voluntary Action Indicated (VAI) |
| Vitalant | Biologics | 02/15/2024 | No Action Indicated (NAI) |
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