James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is unchanged from the number of companies cited in the previous year.
Of the 12 citations issued, the most common citations include:
- You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
- Your quality control personnel did not reject a component when an established specification was not met.
- You did not identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification was met.
Most of the companies cited were involved in the Food and Cosmetics sector.
All of the 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 |
---|---|---|---|
E. Z. Orchards, Inc. | Food and Cosmetics | 09/01/2023 | Pest contamination in buildings |
E. Z. Orchards, Inc. | Food and Cosmetics | 09/01/2023 | Plumbing size, design, installation, and maintenance |
Highland Laboratories, Inc. | Food and Cosmetics | 03/10/2023 | Component - verify identity, dietary ingredient |
Highland Laboratories, Inc. | Food and Cosmetics | 03/10/2023 | Quality control - reject; specification not met |
Highland Laboratories, Inc. | Food and Cosmetics | 03/10/2023 | Examination, testing; scientifically valid |
Highland Laboratories, Inc. | Food and Cosmetics | 03/10/2023 | Quality control production, process control; material review, disposition |
Highland Laboratories, Inc. | Veterinary | 03/10/2023 | Component - verify identity, dietary ingredient |
Highland Laboratories, Inc. | Veterinary | 03/10/2023 | Quality control - reject; specification not met |
Highland Laboratories, Inc. | Veterinary | 03/10/2023 | Examination, testing; scientifically valid |
Highland Laboratories, Inc. | Veterinary | 03/10/2023 | Quality control production, process control; material review, disposition |
Lucas & Son, Inc. | Food and Cosmetics | 07/20/2023 | Food contact surface sanitary inspection and maintenance |
Lucas & Son, Inc. | Food and Cosmetics | 07/20/2023 | Domesticated animal excreta and litter |