There was one company in a city associated with Cumberland County that received FDA citations as a result of one inspection conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is unchanged from the number of companies cited in the previous year.
The citations in the county include:
- The personnel you identified to perform quality control operations do not have the education, training or experience to perform the assigned functions.
- You did not establish written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement.
- You did not establish an identity specification for each component.
The company cited was involved in the Food and Cosmetics sector.
The company cited had to take regulatory and/or administrative actions.
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 |
|---|---|---|---|
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Personnel – quality control personnel – qualified |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Procedures – calibrating instruments |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Specifications – component identity |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Specifications – contamination limits |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Specifications – contamination limits |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Specifications – identity, purity, strength, composition |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Specifications – finished packaging, labeling |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Written procedures – quality control operations |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Records – receiving; components, packaging, labels, products |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Batch record – complete |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Conditions, controls -protect; microorganisms, contamination |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Records – manufacturing operations; written procedures |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Labels – issuance, use |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Written procedures – holding |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Records – returned dietary supplement: written procedures |
| Warner Herb Company | Food and Cosmetics | 02/27/2024 | Written procedures – product complaint |
