There was one company in a city associated with Onondaga County that received FDA citations as a result of one inspection conducted in the county over the first quarter of 2025, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- Procedures for design control have not been established.
- The results of design validation, including identification of the design, method(s), the date and the individual(s) performing validation, were not adequately documented in the design history file.
- Records of complaint investigations do not include required information.
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 |
|---|---|---|---|
| Harmonic Energetic Technologies, Inc. | Devices | 03/07/2025 | Design control – no procedures |
| Harmonic Energetic Technologies, Inc. | Devices | 03/07/2025 | Design validation – documentation |
| Harmonic Energetic Technologies, Inc. | Devices | 03/07/2025 | Records of complaint investigation |
| Harmonic Energetic Technologies, Inc. | Devices | 03/07/2025 | Devices subject to device identification GUDID data submission requirements. |
