Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 50% decrease from the number of companies cited in the previous year.
The citations in the county include:
- Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- Routine inspection and checking of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
- Written procedures are lacking which describe in sufficient detail the sampling, testing, approval and rejection of components.
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 Drugs sector.
Of the companies cited, six should take voluntary actions to correct their managing operations (85.7%). Additionally, one company had to take regulatory and/or administrative actions (14.3%).
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 |
|---|---|---|---|
| Accupack Midwest, Inc. | Drugs | 02/27/2024 | Cleaning / Sanitizing / Maintenance |
| Accupack Midwest, Inc. | Drugs | 02/27/2024 | Calibration/Inspection/Checking not done |
| Accupack Midwest, Inc. | Drugs | 02/27/2024 | Procedures To Be in Writing |
| Accupack Midwest, Inc. | Drugs | 02/27/2024 | Absence of Written Procedures |
| Octapharma Plasma, Inc. | Biologics | 01/10/2024 | Establish, maintain and follow manufacturing SOPs |
| The Gorilla Glue Company | Drugs | 02/23/2024 | Procedures not in writing, fully followed |
| The Gorilla Glue Company | Drugs | 02/23/2024 | Valid stability test methods |
| The Gorilla Glue Company | Drugs | 02/23/2024 | In-process and laboratory control results |
| The Gorilla Glue Company | Drugs | 02/23/2024 | Investigations of discrepancies, failures |
| The Gorilla Glue Company | Drugs | 02/23/2024 | Complaint Handling Procedure |
| The Gorilla Glue Company | Drugs | 02/23/2024 | Complaints reviewed by Quality Control Unit |
| The Kroger Company | Food and Cosmetics | 01/10/2024 | Develop FSVP |
| The Kroger Company | Food and Cosmetics | 01/10/2024 | Hazard analysis written |
| The Kroger Company | Food and Cosmetics | 01/10/2024 | Reevaluate - 3 years |
| The Kroger Company | Food and Cosmetics | 01/10/2024 | Identification - entry |
| The Kroger Company | Food and Cosmetics | 03/19/2024 | Review not timely |
| The Kroger Company | Food and Cosmetics | 03/19/2024 | Appropriate quality control operations |
| The Kroger Company | Food and Cosmetics | 03/19/2024 | Process control - Foreign objects |
| Tobu Corporation | Food and Cosmetics | 04/18/2024 | Manufacturing, processing, packing, holding - Controls |
| Tobu Corporation | Food and Cosmetics | 04/18/2024 | Storage and Distribution |
| Tobu Corporation | Food and Cosmetics | 04/18/2024 | Signed and dated |
| United Dairy Farmers, Inc. | Food and Cosmetics | 12/23/2024 | Raw materials and rework controls - Filth and contamination |
| United Dairy Farmers, Inc. | Food and Cosmetics | 12/23/2024 | Supply-chain program - Implement |
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