Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is a 50% increase over the number of companies cited in the previous year.
The citations in the county include:
- Procedures for the acceptance of in-process product have not been adequately established.
- A device history record has not been adequately maintained.
- You did not implement adequate temperature controls, monitoring, corrective action and verification for foods that require temperature control for safety.
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 |
---|---|---|---|
Dilgard Frozen Foods, Inc. | Food and Cosmetics | 06/28/2024 | Modified requirement: Temperature control - Implement |
Ft Wayne Metal Resch Prod, Corp. | Devices | 05/10/2024 | Lack of or inadequate In-process acceptance procedures |
Ft Wayne Metal Resch Prod, Corp. | Devices | 05/10/2024 | DHR - not or inadequately maintained |
Kyaw Khin, Inc. | Food and Cosmetics | 08/09/2024 | Develop FSVP |