North Chester Today

There were two companies in cities associated with Chester County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2025, 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:

• Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
• Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Both 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.

Company Name	Area of Business	Inspection Date	Issue Cited
Frontage Laboratories, Inc.	Veterinary	01/10/2025	Reports of Analysis (Components)
Frontage Laboratories, Inc.	Veterinary	01/10/2025	Scientifically sound laboratory controls
Frontage Laboratories, Inc.	Veterinary	01/10/2025	Investigations of discrepancies, failures
Veltek Associates, Inc.	Drugs	02/06/2025	Test methods