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 80% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- You did not ensure that the tests or examinations that you used to determine whether the specifications are met are appropriate, scientifically valid methods.
- Your quality control personnel did not reject a dietary supplement, package and label when an established specification was not met.
- You did not establish laboratory control processes for use of criteria for establishing appropriate specifications.
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 |
---|---|---|---|
Quality Supplement Manufacturing, Inc. | Food and Cosmetics | 10/18/2023 | Tests, examinations - scientifically valid |
Quality Supplement Manufacturing, Inc. | Food and Cosmetics | 10/18/2023 | Quality control - reject; specification not met |
Quality Supplement Manufacturing, Inc. | Food and Cosmetics | 10/18/2023 | Criteria for establishing specifications |