Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is a 200% increase over the number of companies cited in the previous quarter.
Of the 11 citations issued, the most common citation was 'Your quality control operations did not include approving, and releasing from quarantine, all components before they were used'.
All 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 |
---|---|---|---|
Geneva Manufacturing, LLC | Food and Cosmetics | 11/15/2023 | Specifications - component identity |
Geneva Manufacturing, LLC | Food and Cosmetics | 11/15/2023 | Specifications-component purity, strength, composition |
Geneva Manufacturing, LLC | Food and Cosmetics | 11/15/2023 | Specifications - contamination limits |
Geneva Manufacturing, LLC | Food and Cosmetics | 11/15/2023 | Specifications - identity, purity, strength, composition |
Geneva Manufacturing, LLC | Food and Cosmetics | 11/15/2023 | Document - material review, disposition |
Geneva Manufacturing, LLC | Food and Cosmetics | 11/15/2023 | Quality control operations - quarantine |
Gramercy Bakery | Food and Cosmetics | 10/13/2023 | Plant operations - Precautions |
Gramercy Bakery | Food and Cosmetics | 10/13/2023 | Storage and Distribution |
Hard Eight Nutrition, LLC | Food and Cosmetics | 10/04/2023 | Quality control operations - quarantine |
Hard Eight Nutrition, LLC | Food and Cosmetics | 10/04/2023 | Quality control operations - finished batch, specifications |
Hard Eight Nutrition, LLC | Food and Cosmetics | 10/04/2023 | Sanitation preventive controls - Appropriate (Adequate) |