There was one company in a city associated with Gloucester County that received FDA citations as a result of one inspection conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 75% decrease from the number of companies cited in the previous year.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing.
- Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
- There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
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.
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 |
|---|---|---|---|
| AAA Pharmaceutical, Inc. | Drugs | 05/15/2024 | Procedures not in writing, fully followed |
| AAA Pharmaceutical, Inc. | Drugs | 05/15/2024 | Absence of Written Procedures |
| AAA Pharmaceutical, Inc. | Drugs | 05/15/2024 | Investigations of discrepancies, failures |
