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Charleston Reporter

Thursday, October 17, 2024

How many companies in cities in Berkeley County received FDA inspections in Q1 2023?

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DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website

There were 10 companies in cities associated with Berkeley County, South Carolina, that received 10 FDA inspections in the first quarter of 2023, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 900% increase over the number of companies inspected in the previous quarter, when one company received one inspection.

Most of the companies inspected at the time were involved in the Biologics sector. Both the Food and Cosmetics and Devices sectors sectors tied for second most common type.

There were nine companies in line with FDA regulations that do not need to adjust their management operations or regulatory/administrative actions (90%). One should take voluntary action to correct its management operations (10%).

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.

Companies Located in Cities Within Berkeley County and Their Inspection Results
Company NameArea of BusinessInspection DateResult
ADMA BioCenters Georgia, Inc.Biologics02/03/2023No Action Indicated (NAI)
Carolina Sports and Orthopedics Sales, Inc.Devices03/01/2023Voluntary Action Indicated (VAI)
Gourmet Distribution, LLCFood and Cosmetics01/06/2023No Action Indicated (NAI)
Medical University Hospital Authority Laboratory ServicesBiologics02/02/2023No Action Indicated (NAI)
Michael E. Field, M.D.Devices01/17/2023No Action Indicated (NAI)
RSI Leasing, Inc.Food and Cosmetics01/27/2023No Action Indicated (NAI)
Ralph H. Johnson Department of VA Medical Center Blood BankBiologics03/21/2023No Action Indicated (NAI)
The American National Red CrossBiologics03/23/2023No Action Indicated (NAI)
The American National Red CrossBiologics03/16/2023No Action Indicated (NAI)
We Are Sharing Hope SchoolBiologics03/14/2023No Action Indicated (NAI)

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