Aspen Biopharma Labs, based in Telangana, has come under scrutiny by the US Food and Drug Administration (USFDA) for several critical lapses in its active pharmaceutical ingredient (API) manufacturing facility. Following an inspection in September 2024, the USFDA issued a warning letter citing significant violations of Current Good Manufacturing Practices (CGMP). These lapses include inadequate facility design, failure to meet equipment validation standards, and failure to conduct proper stability testing of API products.