How many companies in cities across Rockland County received FDA citations in 2024?

How many companies in cities across Rockland County received FDA citations in 2024?
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA — Official Website
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There were four companies in cities associated with Rockland County that received FDA citations as a result of four inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 33.3% increase over the number of companies cited in the previous year.

Of the 15 citations issued, the most common citation was ‘Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel’.

All of the companies cited were involved in the Drugs sector.

All of the companies cited should take voluntary actions to correct their managing 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 quality.

Companies Located Within Rockland County Cities and the Citations They Received in 2024
Company Name Area of Business Inspection Date Issue Cited
Chartwell Life Sciences, LLC Drugs 04/08/2024 Interval
Chartwell Life Sciences, LLC Drugs 04/08/2024 Late submission of annual safety reports
Chartwell Life Sciences, LLC Drugs 04/08/2024 Late submission of quarterly safety reports
Chartwell Life Sciences, LLC Drugs 04/08/2024 Timely submission
Intercos America, Inc. Drugs 10/09/2024 Computer control of master formula records
RK Pharma, Inc. Drugs 05/31/2024 Equipment Design, Size and Location
RK Pharma, Inc. Drugs 05/31/2024 Cleaning / Sanitizing / Maintenance
RK Pharma, Inc. Drugs 05/31/2024 Computer control of master formula records
RK Pharma, Inc. Drugs 05/31/2024 Scientifically sound laboratory controls
RK Pharma, Inc. Drugs 05/31/2024 Records of disposition of rejected material
Vitane Pharmaceutical, Inc. Drugs 10/23/2024 Cleaning / Sanitizing / Maintenance
Vitane Pharmaceutical, Inc. Drugs 10/23/2024 Reports of Analysis (Components)
Vitane Pharmaceutical, Inc. Drugs 10/23/2024 Absence of Written Procedures
Vitane Pharmaceutical, Inc. Drugs 10/23/2024 Storage under appropriate conditions
Vitane Pharmaceutical, Inc. Drugs 10/23/2024 Records reviewed annually


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