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 an increase over the number of companies cited in the previous year.
The citations in the county include:
- You did not establish a specification for a point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.
- You did not establish and follow written procedures for holding and distributing operations.
- You did not establish and follow written procedures for when a returned dietary supplement is received.
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 |
---|---|---|---|
Ozona Organics, LLC | Food and Cosmetics | 06/29/2023 | Specifications - manufacturing process |
Ozona Organics, LLC | Food and Cosmetics | 06/29/2023 | Written procedures - holding |
Ozona Organics, LLC | Food and Cosmetics | 06/29/2023 | Written procedures - returned dietary supplement |
Ozona Organics, LLC | Food and Cosmetics | 06/29/2023 | Written procedures - product complaint |