Tag: Medical Device

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FY 2025 FDA inspection observations visual – quality audit and compliance review with executive hands analyzing reports and regulatory data.

FY 2025 FDA Inspection Observations: Quality Maturity in Drug and Medical Device Manufacturing

FY 2025 FDA inspection observations reveal recurring weaknesses in drug and medical device manufacturing, highlighting quality maturity, governance, and lifecycle...
FDA Issues Warning Letter to Chinese Medical Device Manufacturer for GMP Violations

FDA Issues Warning Letter to Chinese Medical Device Manufacturer for GMP Violations

FDA issues warning letter to Chinese medical device manufacturer for GMP violations, including CAPA failures, inadequate investigations, poor design validation,...

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