483
Rentschler Biopharma Inc.Rentschler Biopharma Inc. – FDA 483, Dec 10, 2025
Record Details
Rentschler Biopharma Inc., a drug substance manufacturer in Milford, MA, received a Form 483 with three observations. Issues included inadequate laboratory controls for analytical methods, insufficient quality review processes for validated spreadsheets leading to calculation errors, and poor organization of retention samples hindering traceability. These observations indicate significant deficiencies in quality control and data integrity.
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ID · d5119927-8e86-4a25-b5ee-5a23c1d26602
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