483
SOCIETAL CDMO SAN DIEGO, LLCSOCIETAL CDMO SAN DIEGO, LLC – FDA 483, Aug 28, 2026
Record Details
An FDA inspection of Societal CDMO San Diego, LLC, a drug manufacturer, revealed significant deficiencies in equipment cleaning validation, water system maintenance, and quality control processes. The firm failed to validate cleaning procedures, maintain its USP Purified Water System free of microbial contamination, and adequately investigate deviations and implement corrective actions in a timely manner. These issues indicate a moderate level of severity regarding GMP compliance.
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ID · ca3b05dc-210d-4e34-bc47-67778dc73353
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