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Talk to a SpecialistTalk to a SpecialistAspen Biopharma Labs Private Limited was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of active pharmaceutical ingredients (APIs), resulting in adulterated drug products. FDA inspectors found that the facility lacked adequate design and construction to prevent contamination, with manufacturing areas exposed to the outdoor environment and insufficient separation between high-risk and toxic materials, including the production of potent drugs in a common, unsegregated area. The facility was described as being in a state of disrepair and was reportedly scheduled for demolition, yet the company continued manufacturing drugs during this period. These deviations violated section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act, rendering the firm's APIs adulterated.