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Tuesday, November 11, 2025

2 companies in a city within Alachua County received two inspections in September

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James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website

James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website

There were two companies in a city associated with Alachua County, Florida, that received two FDA inspections in September, according to the U.S. Food and Drug Administration (FDA).

This is a 33.3% decrease from the number of companies inspected in the previous month, when three companies received three inspections.

The companies inspected operate in the Devices sector.

Both companies were in line with FDA regulations, and don't need to adjust their managing operations or regulatory/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.

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.

Companies Located in a City Within Alachua County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
Nextgen Biologics, Inc.Devices09/04/2025No Action Indicated (NAI)
Novapproach Spine, LLCDevices09/17/2025No Action Indicated (NAI)
Information in this story was obtained from the U.S. Food and Drug Administration. The source data can be found here.

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