DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is a 37.5% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- Your quality control personnel did not conduct required material reviews.
- Your master manufacturing record did not include a description of the packaging and a representative label, or a cross-reference to the physical location of the actual or representative label.
- You did not develop an FSVP.
Most of the companies cited were involved in the Food and Cosmetics sector.
All of the companies cited should take voluntary actions to correct their managing operations.
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 |
|---|---|---|---|
| Bonafide Innovations, LLC | Drugs | 05/06/2024 | GMP Training Frequency |
| Bonafide Innovations, LLC | Drugs | 05/06/2024 | Buildings of Suitable Size, Construction, Location |
| Bonafide Innovations, LLC | Drugs | 05/06/2024 | Written procedures not established/followed |
| Dairyland Produce, LLC | Food and Cosmetics | 04/01/2024 | Storage and Distribution |
| FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Develop FSVP |
| FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Hazard analysis written |
| FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Supplier approval - document |
| FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Reevaluate - 3 years |
| FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Approved supplier procedures - importer established |
| FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Supplier verification - establish written procedures |
| FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Verification activity assurance |
| FMT Services, LLC | Food and Cosmetics | 05/02/2024 | Verification activity before import, periodically |
| Garland Ventures, Ltd. | Food and Cosmetics | 04/19/2024 | Hazard analysis - Identification of hazard |
| Garland Ventures, Ltd. | Food and Cosmetics | 04/19/2024 | Allergen preventive controls - Appropriate (Adequate) |
| Garland Ventures, Ltd. | Food and Cosmetics | 04/19/2024 | Sanitation preventive controls - Appropriate (Adequate) |
| Trace Elements, Inc. | Food and Cosmetics | 06/11/2024 | Material review, disposition - quality control |
| Trace Elements, Inc. | Food and Cosmetics | 06/11/2024 | Packaging description, representative label |
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