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Talk to a SpecialistTalk to a SpecialistToyobo Co. Ltd.'s drug manufacturing facility violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. During a February 2021 inspection, FDA investigators found that the company failed to adequately investigate significant particulate contamination defects in sterile injection solutions, including recurring incidents of extrinsic (foreign) particle contamination across multiple batches in 2019 and 2020. The firm's in-process quality standards and investigation triggers did not sufficiently differentiate between intrinsic and extrinsic particulate contamination, resulting in failures to timely determine root causes and assess product impact as required by 21 CFR 211.192.