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Talk to a SpecialistTalk to a SpecialistSpecialty Process Labs LLC, a drug manufacturer in Phoenix, Arizona, was cited for significant current good manufacturing practice (CGMP) violations in the production of active pharmaceutical ingredients (APIs), specifically thyroid USP API. The company failed to adequately validate its manufacturing processes, particularly several critical processing steps prior to final blending, and did not include key stages in process validation despite commercially releasing lots. Additionally, a performance qualification for blend uniformity failed to meet predetermined acceptance criteria, further undermining the validity of the process validations used to support commercially distributed products.