ePT--the Electronic Newsletter of Pharmaceutical Technology
Dallas, TX (Nov. 7)-The US Food and Drug Administration has posted a Warning Letter from its Dallas District office to Matheson Tri-Gas, Inc.
Dallas, TX (Nov. 7)-The US Food and Drug Administration has posted a Warning Letter (http://www.fda.gov/foi/warning_letters/g6096d.htm) from its Dallas District office to Matheson Tri-Gas, Inc. (Parsippany, NJ, www.mathesontrigas.com). The three-page letter, dated Sept. 12, detailed findings of inspections, in March and April of this year, of a Matheson medical gas facility in Houston, and reviewed the company's April 19 response to the inspectors' Form 483 observations.
The Warning includes three citations, noting shortcomings in:
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.