There were 13 companies in cities associated with Clark County that received FDA citations as a result of 13 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 44.4% increase over the number of companies cited in the previous year.
Of the 51 citations issued, the most common citation was ‘Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained to protect against contamination’.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the Biologics sector.
Of the companies cited, 12 should take voluntary actions to correct their managing operations (92.3%).
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.
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 quality.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Specifications – component identity |
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Specifications-component purity, strength, composition |
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Specifications – contamination limits |
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Specifications – identity, purity, strength, composition |
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Batch record – results; monitoring |
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Batch record – initials; verifying weight |
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Batch record – initials; verifying component |
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Batch record – identifier; labels |
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Batch record – label |
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Batch record – approved, released, rejected; batch |
| Alchemy Nutra, LLC | Food and Cosmetics | 02/14/2024 | Batch record – performance |
| Aqueous Labs, Inc. | Food and Cosmetics | 01/17/2024 | Specifications – component identity |
| Aqueous Labs, Inc. | Food and Cosmetics | 01/17/2024 | Specifications-component purity, strength, composition |
| Aqueous Labs, Inc. | Food and Cosmetics | 01/17/2024 | Specifications – contamination limits |
| Aqueous Labs, Inc. | Food and Cosmetics | 01/17/2024 | Specifications – identity, purity, strength, composition |
| Avatar Foods, Inc. | Food and Cosmetics | 04/29/2024 | Allergen preventive controls – Implement |
| Avatar Foods, Inc. | Food and Cosmetics | 04/29/2024 | Process preventive controls – Implement |
| Avatar Foods, Inc. | Food and Cosmetics | 04/29/2024 | Sanitation preventive controls – Implement |
| Avatar Foods, Inc. | Food and Cosmetics | 04/29/2024 | Supply-chain program – Records |
| Chrisbarry, Inc. | Food and Cosmetics | 12/06/2024 | Cleaning and sanitizing substances – Safe and adequate |
| Chrisbarry, Inc. | Food and Cosmetics | 12/06/2024 | Manufacturing, processing, packing, holding – Controls |
| Chrisbarry, Inc. | Food and Cosmetics | 12/06/2024 | Preventive controls – Implement (Limited Scope only) |
| Chrisbarry, Inc. | Food and Cosmetics | 12/06/2024 | Handling to avoid contamination |
| Donor Services Laboratory Las Vegas, Inc. | Biologics | 04/12/2024 | Manufacturer instructions not followed |
| Donor Services Laboratory Las Vegas, Inc. | Biologics | 04/12/2024 | Deviations–Investigation, documenting, trending |
| Donor Services Laboratory Las Vegas, Inc. | Biologics | 04/12/2024 | Computer software verification |
| Donor Services Laboratory Las Vegas, Inc. | Biologics | 04/12/2024 | Capable of valid results |
| Donor Services Laboratory Las Vegas, Inc. | Biologics | 04/12/2024 | Lot documentation maintained |
| Donor Services Laboratory Las Vegas, Inc. | Biologics | 04/12/2024 | Records incomplete |
| Duane C. Anderson, M.D. | Biologics | 05/24/2024 | FD-1572, protocol compliance |
| George Timothy Kelly., M.D. | Drugs | 02/15/2024 | FD-1572, protocol compliance |
| George Timothy Kelly., M.D. | Drugs | 02/15/2024 | Accountability records |
| Granello Bakery, Inc. | Food and Cosmetics | 11/14/2024 | Sanitary operations – Plant maintenance |
| Granello Bakery, Inc. | Food and Cosmetics | 11/14/2024 | Equipment and utensils – Design and maintenance |
| Granello Bakery, Inc. | Food and Cosmetics | 11/14/2024 | Food safety plan |
| LSG Sky Chefs, Inc. | Food and Cosmetics | 12/17/2024 | Sanitary operations – Plant maintenance |
| LSG Sky Chefs, Inc. | Food and Cosmetics | 12/17/2024 | Sanitation of food-contact surfaces – Frequency |
| LSG Sky Chefs, Inc. | Food and Cosmetics | 12/17/2024 | Equipment and utensils – Design and maintenance |
| LSG Sky Chefs, Inc. | Food and Cosmetics | 12/17/2024 | Manufacturing, processing, packing, holding – Controls |
| LSG Sky Chefs, Inc. | Food and Cosmetics | 12/17/2024 | Hazard analysis – Identification of hazard |
| LSG Sky Chefs, Inc. | Food and Cosmetics | 12/17/2024 | Sanitation preventive controls – Implement |
| LSG Sky Chefs, Inc. | Food and Cosmetics | 12/17/2024 | Supply-chain program – Assurance (Adequate) |
| Lakeview Cheese Products, LLC | Food and Cosmetics | 03/11/2024 | Equipment and utensils – Design and maintenance |
| Matsun Nutrition, Inc. | Food and Cosmetics | 07/09/2024 | Quality control production, process control; material review, disposition |
| Matsun Nutrition, Inc. | Food and Cosmetics | 07/09/2024 | Batch record – initials; component |
| Nevada Diabetes Association for Children & Adults, Inc. | Devices | 05/08/2024 | Labeling requirements for stand-alone software |
| Tortillas Incorporated | Food and Cosmetics | 10/24/2024 | Sanitary operations – Plant maintenance |
| Tortillas Incorporated | Food and Cosmetics | 10/24/2024 | Sanitary operations – Plant sanitation |
| Tortillas Incorporated | Food and Cosmetics | 10/24/2024 | Pest control |
| Tortillas Incorporated | Food and Cosmetics | 10/24/2024 | Equipment and utensils – Design and maintenance |
| Tortillas Incorporated | Food and Cosmetics | 10/24/2024 | Storage and Distribution |

