There were two companies in a city associated with Knox County that received FDA citations as a result of two inspections conducted in the county over the first quarter of 2025, 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 quarter.
The citations in the county include:
- Your hazard analysis did not identify a hazard that required a preventive control.
- You did not identify an allergen preventive control for a hazard when one was needed.
- Your written process preventive control procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control.
The companies cited were involved in either Food and Cosmetics or Drugs sectors.
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 |
|---|---|---|---|
| Quality Bakers | Food and Cosmetics | 01/30/2025 | Hazard analysis – Identification of hazard |
| Quality Bakers | Food and Cosmetics | 01/30/2025 | Allergen preventive controls – Identify (Written) |
| Quality Bakers | Food and Cosmetics | 01/30/2025 | Process preventive controls – Appropriate (Adequate) |
| Scapa Tapes North America, LLC | Drugs | 01/23/2025 | Procedures not in writing, fully followed |
| Scapa Tapes North America, LLC | Drugs | 01/23/2025 | Approval and review of procedures |
| Scapa Tapes North America, LLC | Drugs | 01/23/2025 | Written in-process control procedures |
| Scapa Tapes North America, LLC | Drugs | 01/23/2025 | Following/documenting laboratory controls |
