Warning letter to Utah firm highlights contract manufacturing, FSMA questions

BI says steam sterilization gives it a leg up on FSMA supply chain rule

15-Jan-2018

By Hank Schultz

With 15 years of data, BI Nutraceuticals says its steam sterilization protocol is the most highly developed in the dietary supplement industry, and is part of what enables the company to fully comply with FSMA requirements.

FDA to delay enforcement on four FSMA rules

08-Jan-2018

By Hank Schultz

Some of the provisions of the Food Safety Modernization Act will be delayed in implementation while FDA works through potential problems that were identified in the comments phase, the agency announced last week.

FDA now wants responses to foreign facility inspection requests within 24 hours

20-Dec-2017

By Hank Schultz

Foreign food facilities run the risk of ending up on import alert if they don’t take note of a change in policy in a recent guidance from the US Food and Drug Administration.

Warning letter to Utah firm highlights contract manufacturing, FSMA questions

A recent warning letter sent to a Utah company by the US Food and Drug Administration lists various GMP violations, including a lack of allergen warnings, something that will only accelerate as FSMA implementation goes into full swing.

Related Topics

BI says steam sterilization gives it a leg up on FSMA supply chain rule

FDA to delay enforcement on four FSMA rules

FDA now wants responses to foreign facility inspection requests within 24 hours