Warning Letter: Merck & Co.
On July 22, the US Food and Drug Administration sent a warning letter to Merck and Company (Whitehouse Station, NJ) concerning the company’s manufacture of asparaginase intermediate used in the drug Elspar to treat acute lymphocytic leukemia.
The agency cited the company for failing to submit a supplement for a change in the production process and quality controls. Specifically, Merck prepared production cell culture from a pre-existing production cell culture instead of from the master cell culture, a change that required the company to file a prior-approval supplement. The company also instituted a re-isolation procedure for selecting cells for use in production of asparaginase intermediate without characterizing the new isolate prior to use in production.
FDA cited these violations in a Form 483 following a February inspection of the company’s plant in Riverside, Pennsylvania. FDA issued the warning letter because it found the company’s responses to the Form 483 to be inadequate.
–Laura Bush
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.