483
LFB USA, Inc.LFB USA, Inc. – FDA 483
Record Details
LFB USA Inc., a biologics manufacturer in Charlton, MA, was cited for significant quality control deficiencies during an FDA inspection. Observations included uninvestigated mold contamination in Sevenfact intermediate manufacturing, inadequate water quality, and insufficient bioburden specifications. The firm also failed in data integrity, document control, stability data reporting, and equipment qualification.
- Company
- LFB USA, Inc.
- Product type
- biologics
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ID · d5cb42c1-4c7a-4485-a0e4-2c96bbb1b239
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