<ul><li>The USFDA has issued a warning letter to Aspen Biopharma Labs for manufacturing lapses at its active pharmaceutical ingredients production facility in Telangana, India.</li><li>The FDA observed significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API) during their inspection in September 2024.</li><li>The letter highlighted issues such as inadequate facility design, lack of appropriate separation for high-risk APIs, disrepair of manufacturing areas, failure to validate processes and equipment, and absence of a stability testing program.</li><li>The USFDA has requested clarification from the company on whether they intend to cease drug manufacturing for the US market and requested notification before any future resumption of operations.</li></ul>

USFDA Pulls Up Aspen Biopharma Labs For Manufacturing Lapses At API Plant

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