There was one company in a city associated with Hawkins County that received FDA citations as a result of one inspection conducted in the county throughout 2023, 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 county include:
- Quality audits were not performed at defined intervals to determine whether the quality system activities and results comply with quality system procedures.
- Procedures for training and identifying training needs have not been established.
- Procedures to ensure equipment is routinely calibrated, checked and maintained have not been 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.
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, according to its website.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Sunshine USA, LLC | Devices | 08/17/2023 | Quality Audits – defined intervals |
| Sunshine USA, LLC | Devices | 08/17/2023 | Training – Lack of or inadequate procedures |
| Sunshine USA, LLC | Devices | 08/17/2023 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Sunshine USA, LLC | Devices | 08/17/2023 | DMR – not or inadequately maintained |
| Sunshine USA, LLC | Devices | 08/17/2023 | DHR – not or inadequately maintained |
| Sunshine USA, LLC | Devices | 08/17/2023 | Lack of or inadequate complaint procedures |
