ePT--the Electronic Newsletter of Pharmaceutical Technology
On July 18, the US Food and Drug Administration posted a Warning Letter issued Watson Laboratories Caribe, Inc. (Corona, CA) by FDA's San Juan (PR) district office.
On July 18, the US Food and Drug Administration posted a Warning Letter issued Watson Laboratories Caribe,Inc. (Corona, CA) by FDA's San Juan (PR) district office. The Warning,dated June 19, cited manufacturing deficiencies at Watson'sHumacao, Puerto Rico facility. According to the letter, a Nov.3–Dec.15, 2005, FDA inspection uncovered significant deviations from currentgood manufacturing practice (CGMP) regulations including:
FDA recommended Watson Laboratories, "take prompt action to correctthese violations, and you should establish procedures whereby suchviolations do not recur. Failure to do so may result in regulatoryaction without further notice, including seizure and/or injunction."
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.