Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | 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 citation was 'You offered food-producing animal(s) for interstate commerce that was found to bear or contain a drug residue in an edible tissue above an established safe level, safe concentration, or tolerance'.
Most of the companies cited were involved in the Veterinary sector.
Of the companies cited, five should take voluntary actions to correct their managing operations (83.3%). Additionally, one company had to take regulatory and/or administrative actions (16.7%).
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 |
---|---|---|---|
Bidart Dairy II, LLC | Veterinary | 05/23/2023 | Introduction/delivery into IS - illegal drug residue |
Boschma and Sons Dairy | Veterinary | 08/24/2023 | Introduction/delivery into IS - illegal drug residue |
Laumiere Gourmet Fruits Company, LLC | Food and Cosmetics | 04/06/2023 | Personnel |
Laumiere Gourmet Fruits Company, LLC | Food and Cosmetics | 04/06/2023 | Manufacturing, processing, packing, holding - Controls |
NV Pets Sales and Marketing | Veterinary | 09/21/2023 | Develop FSVP |
Precision Equine, LLC | Veterinary | 09/22/2023 | Approve or reject components, products |
Precision Equine, LLC | Veterinary | 09/22/2023 | Cleaning / Sanitizing / Maintenance |
Precision Equine, LLC | Veterinary | 09/22/2023 | Component written specification |
Precision Equine, LLC | Veterinary | 09/22/2023 | Procedures for sterile drug products |
Precision Equine, LLC | Veterinary | 09/22/2023 | Testing and release for distribution |
Precision Equine, LLC | Veterinary | 09/22/2023 | Microbiological testing |
Precision Equine, LLC | Veterinary | 09/22/2023 | Lack of written stability program |
Precision Equine, LLC | Veterinary | 09/22/2023 | No written record of investigation |
Vanguard Direct, LLC | Food and Cosmetics | 01/30/2023 | Hazard analysis written |