Rockland Reporter

There was one company in a city associated with Rockland County that received FDA citations as a result of one inspection conducted in the county over the second quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is an increase over the number of companies cited in the previous quarter.

The citations in the county include:

• Periodic reports of non-alert adverse drug experiences have not been submitted yearly for an application which was approved three or more years ago.
• Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
• Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.

The company cited should take a voluntary action to correct its 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.

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.

Company Name	Area of Business	Inspection Date	Issue Cited
Chartwell Pharmaceuticals, LLC	Drugs	04/08/2024	Interval
Chartwell Pharmaceuticals, LLC	Drugs	04/08/2024	Late submission of annual safety reports
Chartwell Pharmaceuticals, LLC	Drugs	04/08/2024	Late submission of quarterly safety reports
Chartwell Pharmaceuticals, LLC	Drugs	04/08/2024	Timely submission