Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is a 100% increase over the number of companies cited in the previous year.
Of the 14 citations issued, the most common citations include:
- You did not establish component specifications for purity, strength and composition.
- You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.
- You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).
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 |
---|---|---|---|
Metabolic Maintenance Products | Food and Cosmetics | 06/14/2023 | Specifications-component purity, strength, composition |
Metabolic Maintenance Products | Food and Cosmetics | 06/14/2023 | Specifications - contamination limits |
Metabolic Maintenance Products | Food and Cosmetics | 06/14/2023 | Specifications - identity, purity, strength, composition |
Metabolic Maintenance Products | Food and Cosmetics | 06/14/2023 | Quality control - batch, product specifications |
Metabolic Maintenance Products | Food and Cosmetics | 06/14/2023 | Record - product complaint; findings |
Oregons Wild Harvest, Inc. | Food and Cosmetics | 02/06/2023 | Tests, examinations - scientifically valid |
Personalized Nutrients | Food and Cosmetics | 06/07/2023 | Specifications - component identity |
Personalized Nutrients | Food and Cosmetics | 06/07/2023 | Specifications-component purity, strength, composition |
Personalized Nutrients | Food and Cosmetics | 06/07/2023 | Specifications - contamination limits |
Personalized Nutrients | Food and Cosmetics | 06/07/2023 | Specifications - identity, purity, strength, composition |
Personalized Nutrients | Food and Cosmetics | 06/07/2023 | Specifications met - contamination limits |
ReNovo, Inc. | Devices | 05/18/2023 | Environmental control Lack of or inadequate procedures |
ReNovo, Inc. | Devices | 05/18/2023 | Periodic equipment inspection lack of or inadequate procedu |
ReNovo, Inc. | Devices | 05/18/2023 | Nonconforming product, Lack of or inadequate procedures |