There were two companies in a city associated with York County that received FDA citations as a result of two inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 33.3% decrease from the number of companies cited in the previous year.
The citations in the county include:
- Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
- Procedures to ensure equipment is routinely calibrated have not been established.
- A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.
All of the companies cited were involved in the Devices sector.
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 |
|---|---|---|---|
| Simpex Medical, Inc. | Devices | 06/28/2024 | Design plans – Lack of or inadequate |
| Simpex Medical, Inc. | Devices | 06/28/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Simpex Medical, Inc. | Devices | 06/28/2024 | Lack of or inadequate process validation |
| Simpex Medical, Inc. | Devices | 06/28/2024 | DHR documentation of label release {see also 820.184} |
| Simpex Medical, Inc. | Devices | 06/28/2024 | Sampling plans |
| Spectrum Medical, Inc. | Devices | 05/24/2024 | Individual Report of Malfunction |
| Spectrum Medical, Inc. | Devices | 05/24/2024 | Procedures not adequately established or maintained |
| Spectrum Medical, Inc. | Devices | 05/24/2024 | Lack of or inadequate complaint procedures |


