Warning Letter: Cape Drugs
Warning Letter: Cape Drugs
On July 11, the US Food and Drug Administration sent a warning letter to Cape Drugs (Annapolis, MD) concerning the company’s compounding of domperidone, a drug not approved by FDA.
According to the warning letter, there have been several published reports linking domperidone to cardiac arrhythmias, cardiac arrest, and sudden death in patients receiving an intravenous form of the drug. FDA notes use of the drug by lactating women to increase breast milk production, but the drug is not approved for this use in any country. Several countries have approved domperidone for treatment of gastric stasis and gastroparesis.
FDA also charged that the products were misbranded and that the labels fail to list adequate directions for use.
–George Koroneos
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.
