Vid Desai FDA’s Chief Information Officer | Official Website
Vid Desai FDA’s Chief Information Officer | Official Website
This is a 25% increase over the number of companies cited in the previous year.
Of the 25 citations issued, the most common citation was 'You did not exclude pests from your food plant to protect against contamination of food'.
Most of the companies cited were involved in either Food and Cosmetics or Veterinary sectors.
Of the companies cited, five should take voluntary actions to correct their managing operations. Additionally, one company had to take regulatory and/or administrative actions (20%).
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 |
---|---|---|---|
D R Small, LLC | Veterinary | 05/10/2023 | Contamination with Mycotoxins/Natural Toxins |
Klarity Medical Products, LLC | Devices | 02/16/2023 | Lack of or inadequate process validation |
Klarity Medical Products, LLC | Devices | 02/16/2023 | Lack of or inadequate procedures - Acceptance activities |
Klarity Medical Products, LLC | Devices | 02/16/2023 | DMR - not or inadequately maintained |
Rocky Fork Formulas, Inc. | Food and Cosmetics | 08/30/2023 | Written procedure quality control operations material review |
Schwebel Baking Company | Food and Cosmetics | 09/29/2023 | Pest control |
Schwebel Baking Company | Food and Cosmetics | 09/29/2023 | Sanitation preventive controls - Implement |
Schwebel Baking Company | Food and Cosmetics | 09/29/2023 | Sanitation preventive controls - Appropriate (Adequate) |
Schwebel Baking Company | Food and Cosmetics | 02/03/2023 | Pest control |
Schwebel Baking Company | Food and Cosmetics | 02/03/2023 | Allergen preventive controls - Implement |
Schwebel Baking Company | Food and Cosmetics | 02/03/2023 | Process preventive controls - Implement |
Schwebel Baking Company | Food and Cosmetics | 02/03/2023 | Sanitation preventive controls - Implement |
Schwebel Baking Company | Veterinary | 02/03/2023 | Pest control |
Schwebel Baking Company | Veterinary | 02/03/2023 | Allergen preventive controls - Implement |
Schwebel Baking Company | Veterinary | 02/03/2023 | Process preventive controls - Implement |
Schwebel Baking Company | Veterinary | 02/03/2023 | Sanitation preventive controls - Implement |
Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Procedures not in writing, fully followed |
Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Computer control of master formula records |
Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Identity Testing of Each Component |
Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Reports of Analysis (Components) |
Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Establishment of time limitations |
Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Scientifically sound laboratory controls |
Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Test methods |
Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Valid stability test methods |
Tri Technician Laboratories, LLC | Drugs | 12/19/2023 | Investigations of discrepancies, failures |