There were 10 companies in a city associated with Denver County that received FDA citations as a result of 10 inspections conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 23.1% decrease from the number of companies cited in the previous year.
Of the 54 citations issued, the most common citations were ‘Your plant did not have adequate sanitary facilities and accommodations’ and ‘You did not exclude pests from your food plant to protect against contamination of food’.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, seven should take voluntary actions to correct their managing operations (70%). Additionally, three companies had to take regulatory and/or administrative actions (30%).
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 |
|---|---|---|---|
| Blue Ocean of Colorado, Inc. | Food and Cosmetics | 02/16/2024 | Hazard analysis |
| Blue Ocean of Colorado, Inc. | Food and Cosmetics | 02/16/2024 | Food safety hazards |
| Blue Ocean of Colorado, Inc. | Food and Cosmetics | 02/16/2024 | Verification procedures – none/frequency |
| Blue Ocean of Colorado, Inc. | Food and Cosmetics | 02/16/2024 | Monitoring record review adequacy |
| Blue Ocean of Colorado, Inc. | Food and Cosmetics | 02/16/2024 | Sanitation monitoring |
| Cardinal Health 414, LLC | Drugs | 09/24/2024 | Adequate controls (general) |
| Conagra Brands, Inc. | Food and Cosmetics | 08/21/2024 | Qualifications of individuals |
| Conagra Brands, Inc. | Food and Cosmetics | 08/21/2024 | Sanitary facilities and controls |
| Conagra Brands, Inc. | Food and Cosmetics | 08/21/2024 | Equipment and utensils – Design and maintenance |
| Dillon Companies, LLC | Food and Cosmetics | 09/11/2024 | Appropriate quality control operations |
| Honey Smoked Fish Holdings, LLC | Food and Cosmetics | 10/15/2024 | HACCP plan implementation |
| Honey Smoked Fish Holdings, LLC | Food and Cosmetics | 10/15/2024 | Critical control points |
| Honey Smoked Fish Holdings, LLC | Food and Cosmetics | 10/15/2024 | Critical limits |
| Honey Smoked Fish Holdings, LLC | Food and Cosmetics | 10/15/2024 | Reassessment of HACCP plan |
| Honey Smoked Fish Holdings, LLC | Food and Cosmetics | 10/15/2024 | Sanitation monitoring documentation |
| Jerry’s Nut House, Inc. | Food and Cosmetics | 11/15/2024 | Personnel |
| Jerry’s Nut House, Inc. | Food and Cosmetics | 11/15/2024 | Grounds |
| Jerry’s Nut House, Inc. | Food and Cosmetics | 11/15/2024 | Cleaning and sanitizing substances – Safe and adequate |
| Jerry’s Nut House, Inc. | Food and Cosmetics | 11/15/2024 | Sanitation of food-contact surfaces – Frequency |
| Jerry’s Nut House, Inc. | Food and Cosmetics | 11/15/2024 | Sanitary facilities and controls |
| Ng Zheng, Inc. | Food and Cosmetics | 10/18/2024 | Pest control |
| Ng Zheng, Inc. | Food and Cosmetics | 10/18/2024 | Hazard analysis – Identification of hazard |
| Ng Zheng, Inc. | Food and Cosmetics | 10/18/2024 | Allergen preventive controls – Appropriate (Adequate) |
| Ng Zheng, Inc. | Food and Cosmetics | 10/18/2024 | Supply-chain program – Implement |
| Optikem International, Inc. | Devices | 03/01/2024 | Design verification – Lack of or inadequate procedures |
| Optikem International, Inc. | Devices | 03/01/2024 | Design Validation – Risk analysis not performed/inadequate |
| Optikem International, Inc. | Devices | 03/01/2024 | Design validation- Lack of or inadequate procedures |
| Optikem International, Inc. | Devices | 03/01/2024 | Environmental control Lack of or inadequate procedures |
| Optikem International, Inc. | Devices | 03/01/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| Optikem International, Inc. | Devices | 03/01/2024 | Lack of or inadequate process validation |
| Optikem International, Inc. | Devices | 03/01/2024 | Lack of or inadequate procedures |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Qualifications of individuals |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Pest control |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Food safety plan |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Containers kept sanitary |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Product water samples after processing |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Records – equipment inspection |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Mechanical washers – records |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Sample, test – cleaning, sanitizing solutions |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Package identification |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Records – product, volume, date, code, distribution |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Bacteriological swab, rinse count – containers, closures (S) |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Bacteriological test – bottled water |
| PureWater Dynamics, Inc. | Food and Cosmetics | 07/31/2024 | Representative samples – bottled water |
| Western Innovations, Inc. | Food and Cosmetics | 02/21/2024 | Personnel – hygienic practices |
| Western Innovations, Inc. | Food and Cosmetics | 02/21/2024 | Specifications – component identity |
| Western Innovations, Inc. | Food and Cosmetics | 02/21/2024 | Specifications-component purity, strength, composition |
| Western Innovations, Inc. | Food and Cosmetics | 02/21/2024 | Specifications – contamination limits |
| Western Innovations, Inc. | Food and Cosmetics | 02/21/2024 | Specifications – contamination limits |
| Western Innovations, Inc. | Food and Cosmetics | 02/21/2024 | Specifications – identity, purity, strength, composition |
| Western Innovations, Inc. | Food and Cosmetics | 02/21/2024 | Written procedures – quality control operations |
| Western Innovations, Inc. | Food and Cosmetics | 02/21/2024 | Master manufacturing record – each batch |
| Western Innovations, Inc. | Food and Cosmetics | 02/21/2024 | Batch record – complete |
| Western Innovations, Inc. | Food and Cosmetics | 02/21/2024 | Records – returned dietary supplement: written procedures |
