FDA conducts Feb. 6 inspection of CAREstream Medical, Ltd. in Lake Mary

Melanie Keller, Deputy Commissioner for Operations and Chief Operating Officer of FDA
Melanie Keller, Deputy Commissioner for Operations and Chief Operating Officer of FDA
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The Food and Drug Administration (FDA) inspected CAREstream Medical, Ltd. in Lake Mary on Feb. 6, as shown in data available on the FDA’s website.

The inspection addressed the following topics:

  • Compliance: Devices
  • Postmarket Assurance: Devices

The inspection’s final report recommended voluntary corrective actions to improve the organization’s managing operations at CAREstream Medical, Ltd.

The FDA regularly inspects facilities nationwide to verify that operations and products meet federal regulations for public health, with results released to the public.

The FDA’s website states the agency mainly oversees the safety and quality of human and animal drugs, biological products, medical supplies, and tobacco products throughout their production and distribution.

Information for this story was sourced from the U.S. Food and Drug Administration. Source data is available here.



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