There was one company in the City of Danville that received FDA citations as a result of one inspection conducted in the city throughout 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 year.
The citations in the city include:
- Procedures for quality audits have not been adequately established.
- Procedures for design validation have not been established.
- Procedures for design change have not been adequately established.
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 |
|---|---|---|---|
| Electronic Development Labs, Inc. | Devices | 08/08/2024 | Quality audits – Lack of or inadequate procedures |
| Electronic Development Labs, Inc. | Devices | 08/08/2024 | Design validation- Lack of or inadequate procedures |
| Electronic Development Labs, Inc. | Devices | 08/08/2024 | Design changes – Lack of or Inadequate Procedures |
| Electronic Development Labs, Inc. | Devices | 08/08/2024 | Lack of or inadequate DHR procedures |
