Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
This is unchanged from the number of companies cited in the previous month.
The citations in the county include:
- You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food.
- You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.
- You did not determine and document which verification activity or activities were needed to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.
Both 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 |
---|---|---|---|
Micro Precision Swiss | Devices | 09/12/2024 | Lack of or inadequate In-process acceptance procedures |
Micro Precision Swiss | Devices | 09/12/2024 | Lack of or inadequate procedures |
Pura Vida Farms, LLC | Food and Cosmetics | 09/10/2024 | Evaluation - performance, risk |
Pura Vida Farms, LLC | Food and Cosmetics | 09/10/2024 | Supplier verification - establish written procedures |
Pura Vida Farms, LLC | Food and Cosmetics | 09/10/2024 | Verification activity assurance |