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 50% increase over the number of companies cited in the previous year.
Of the 20 citations issued, the most common citations were 'You did not establish and follow written procedures for holding and distributing operations' and 'You did not establish and follow written procedures for the requirements to review and investigate a product complaint'.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).
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 |
---|---|---|---|
Allison Medical, Inc. | Devices | 04/28/2023 | Files do not contain copies of MDR reports |
Allison Medical, Inc. | Devices | 04/28/2023 | Procedures not adequately established or maintained |
Allison Medical, Inc. | Devices | 04/28/2023 | Software validation for automated processes |
Allison Medical, Inc. | Devices | 04/28/2023 | Lack of or inadequate procedures |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Procedures - equipment - cleaning, sanitizing |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Specifications - component identity |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Specifications-component purity, strength, composition |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Specifications - identity, purity, strength, composition |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Component - qualify supplier |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Written procedures - quality control operations |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Master manufacturing record - unique formulation |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Batch record - complete |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Batch record - quality control review; production |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Written procedures - holding |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Written procedures returned dietary supplement investigation |
Osmosis, LLC | Food and Cosmetics | 01/13/2023 | Written procedures - product complaint |
Wild Warrior Nutrition, LLC | Food and Cosmetics | 07/14/2023 | Written procedure quality control operations material review |
Wild Warrior Nutrition, LLC | Food and Cosmetics | 07/14/2023 | Written procedures - holding |
Wild Warrior Nutrition, LLC | Food and Cosmetics | 07/14/2023 | Records - returned dietary supplement: written procedures |
Wild Warrior Nutrition, LLC | Food and Cosmetics | 07/14/2023 | Written procedures - product complaint |