FDA conducts inspection at Gastroklenz, Inc. in San Francisco on Aug. 15, 2024

Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration - Official Website
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On August 15, 2024, the Food and Drug Administration conducted an inspection of Gastroklenz, Inc. in San Francisco, according to data posted on the FDA’s website.

The inspection covered the following areas:

  • Compliance: Devices
  • Postmarket Assurance: Devices

The FDA’s final report concluded that Gastroklenz, Inc. is not required to implement any corrective actions regarding 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.

According to its website, 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 and quality.

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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