There was one company in a city associated with Palm Beach County that received FDA citations as a result of one inspection conducted in the county in September, according to the U.S. Food and Drug Administration (FDA).
This is a 66.7% decrease from the number of companies cited in the previous month.
The citations in the county include:
- Written procedures are lacking which describe in sufficient detail the approval and rejection of components.
- Representative samples are not taken of each shipment of each lot of components for testing or examination.
- There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications 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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Oxygen Development, LLC | Drugs | 09/11/2025 | Procedures To Be in Writing |
| Oxygen Development, LLC | Drugs | 09/11/2025 | Representative Samples |
| Oxygen Development, LLC | Drugs | 09/11/2025 | Investigations of discrepancies, failures |
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
