James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is a 100% increase over the number of companies cited in the previous month.
Of the six citations issued, the most common citations were 'Procedures for finished device acceptance have not been adequately established' and 'Procedures for corrective and preventive action have not been adequately established'.
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.
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 and quality.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
Simple Science, LLC | Devices | 08/07/2025 | Evaluation of suppliers, contractors, etc., requirements |
Simple Science, LLC | Devices | 08/07/2025 | Lack of or inadequate final acceptance procedures |
Simple Science, LLC | Devices | 08/07/2025 | Nonconforming product, Lack of or inadequate procedures |
Simple Science, LLC | Devices | 08/07/2025 | Lack of or inadequate procedures |
Steris Laboratories | Devices | 08/01/2025 | Lack of or inadequate final acceptance procedures |
Steris Laboratories | Devices | 08/01/2025 | Lack of or inadequate procedures |