483
AbbVie Bioresearch CenterFDA 483 - AbbVie Bioresearch Center
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Record Details
An FDA inspection of AbbVie Bioresearch Center in Worcester, MA, identified an issue with microbiology methods. The firm was cited for not adequately conducting these methods, specifically regarding the use of qualified inoculum or previously approved media batches for growth promotion acceptance criteria. This indicates a concern with quality control in their drug substance manufacturing processes.
- Company
- AbbVie Bioresearch Center
- Product Type
- Drugs
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ID · 80e5e8eb-3991-4bd1-974d-279b0bbf2aba