Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is an increase over the number of companies cited in the previous year.
The citations in the county include:
- You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.
- You did not collect representative samples of finished batches of dietary supplements that you manufacture to verify that the finished batch of dietary supplement meets established product specifications.
- You did not prepare and follow a written master manufacturing record for each batch size of a dietary supplement that you manufactured.
All of the companies cited were involved in the Food and Cosmetics 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.
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 |
---|---|---|---|
Damon Industries | Food and Cosmetics | 07/11/2023 | Personnel |
Damon Industries | Food and Cosmetics | 07/11/2023 | Sanitary operations - Plant maintenance |
Damon Industries | Food and Cosmetics | 07/11/2023 | Cleaning and sanitizing substances - Safe and adequate |
Damon Industries | Food and Cosmetics | 07/11/2023 | Equipment and utensils - Design and maintenance |
Damon Industries | Food and Cosmetics | 07/11/2023 | Plant operations - Precautions |
Kimmie Candy Company | Food and Cosmetics | 09/19/2023 | Specifications - identity, purity, strength, composition |
Kimmie Candy Company | Food and Cosmetics | 09/19/2023 | Specifications - representative samples; finished batch |
Kimmie Candy Company | Food and Cosmetics | 09/19/2023 | Master manufacturing record - each batch |