483
Lilly del Caribe, Inc.Lilly del Caribe, Inc. – FDA 483, Feb 17, 2023
Record Details
An FDA inspection of Lilly del Caribe, Inc. in Carolina, PR, revealed two significant observations regarding quality unit failures. The firm failed to thoroughly investigate a microbial contamination discrepancy in a drug substance batch, leading to insufficient corrective actions. Additionally, the quality unit did not properly review and approve batch records and quality-related documents, resulting in manufacturing issues due to unapproved and untrailed procedural changes.
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ID · 0077c94c-6068-4f48-9c88-b92150dd9273
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