Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 66.7% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing.
- Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).
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 |
|---|---|---|---|
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Process filing |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Quality control procedures |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Code - required elements |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Process deviations- identification and records |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Pest control |
| Cordoba Foods, LLC | Food and Cosmetics | 01/31/2025 | Hazard analysis - Identification of hazard |
| Evi Labs | Drugs | 01/15/2025 | Procedures not in writing, fully followed |
| Evi Labs | Drugs | 01/15/2025 | Cleaning / Sanitizing / Maintenance |
| Evi Labs | Drugs | 01/15/2025 | Calibration/Inspection/Checking not done |
| Evi Labs | Drugs | 01/15/2025 | Computer control of master formula records |
| Evi Labs | Drugs | 01/15/2025 | Reports of Analysis (Components) |
| Evi Labs | Drugs | 01/15/2025 | Control procedures to monitor and validate performance |
| Evi Labs | Drugs | 01/15/2025 | Scientifically sound laboratory controls |
| Evi Labs | Drugs | 01/15/2025 | Testing and release for distribution |
| Evi Labs | Drugs | 01/15/2025 | Lack of written stability program |
| Evi Labs | Drugs | 01/15/2025 | Dates not included for each significant step |
| Shagalla, Inc. | Food and Cosmetics | 02/24/2025 | HACCP plan implementation |
| Shagalla, Inc. | Food and Cosmetics | 02/24/2025 | HACCP plan location |
| Shagalla, Inc. | Food and Cosmetics | 02/24/2025 | Signed and dated |
| Shagalla, Inc. | Food and Cosmetics | 02/24/2025 | Sanitation monitoring |
| Shagalla, Inc. | Food and Cosmetics | 02/24/2025 | Importer verification |
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