There were 11 companies in cities associated with Bernalillo County that received FDA citations as a result of 11 inspections conducted in the county in 2024, according to the U.S. Food and Drug Administration (FDA).
This is a 266.7% increase over the number of companies cited in the previous year.
Of the 26 citations issued, the most common citations include:
- You did not clean and sanitize your utensils or equipment in a manner that protects against allergen cross-contact.
- Acidified food is not manufactured in accordance with the scheduled process.
- An investigation was not conducted in accordance with the investigational plan.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company operated in the Drugs sector.
Of the companies cited, nine should take voluntary actions to correct their managing operations (81.8%). Additionally, two companies had to take regulatory and/or administrative actions (18.2%).
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.
According to its website, 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 and quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Andrews Candy Company, LLC. | Food and Cosmetics | 11/27/2024 | Sanitary operations – Plant sanitation |
| Apple Canyon Gourmet, Inc. | Food and Cosmetics | 09/09/2024 | Scheduled process |
| Cardinal Health 414, LLC | Drugs | 09/25/2024 | Written QA procedures established, followed |
| Cardinal Health 414, LLC | Drugs | 09/25/2024 | Stability testing program |
| Carrie D. Swartz, M.D. | Drugs | 11/22/2024 | FD-1572, protocol compliance |
| Indio Hispano Native Foods, LLC | Food and Cosmetics | 01/11/2024 | Sanitary operations – Plant sanitation |
| National Railroad Passenger Corporation – Amtrak | Food and Cosmetics | 11/20/2024 | Prevention of contamination |
| New Mexico Lions Sight Conservation Foundation, Inc. | Biologics | 02/28/2024 | Design of procedures to ensure compliance |
| New Mexico Lions Sight Conservation Foundation, Inc. | Biologics | 02/28/2024 | Donors with risks not determined ineligible |
| Sombra Cosmetics, Inc. | Drugs | 07/26/2024 | Procedures not in writing, fully followed |
| Sombra Cosmetics, Inc. | Drugs | 07/26/2024 | Component identity verification |
| Sombra Cosmetics, Inc. | Drugs | 07/26/2024 | Absence of Written Procedures |
| Sombra Cosmetics, Inc. | Drugs | 07/26/2024 | Scientifically sound laboratory controls |
| Sombra Cosmetics, Inc. | Drugs | 07/26/2024 | Test methods |
| Sombra Cosmetics, Inc. | Drugs | 07/26/2024 | Lack of written stability program |
| Sombra Cosmetics, Inc. | Drugs | 07/26/2024 | Records reviewed annually |
| Sombra Cosmetics, Inc. | Drugs | 07/26/2024 | Extent of discrepancy, failure investigations |
| Southwest Airlines, Inc. | Food and Cosmetics | 11/22/2024 | Prevention of contamination |
| Southwest Airlines, Inc. | Food and Cosmetics | 11/22/2024 | Adequate and readily accessible |
| Southwest Airlines, Inc. | Food and Cosmetics | 11/22/2024 | Persons handling soil cans and other containers |
| Sugar Moon Syrups, LLC | Food and Cosmetics | 06/14/2024 | Scheduled process |
| Sugar Moon Syrups, LLC | Food and Cosmetics | 06/14/2024 | Container testing |
| Sugar Moon Syrups, LLC | Food and Cosmetics | 06/14/2024 | Process deviation |
| Sugar Moon Syrups, LLC | Food and Cosmetics | 06/14/2024 | Raw materials, packaging, finished product |
| Susan Seedman, M.D. | Devices | 08/30/2024 | Compensation, medical treatment in event of injury |
| Susan Seedman, M.D. | Devices | 08/30/2024 | Investigator non-compliance with agreement/plan/regulations |
