483
GlaxoSmithKline, LLC.GlaxoSmithKline, LLC. – FDA 483
Record Details
An FDA inspection of GlaxoSmithKline, LLC in Conshohocken, PA, a drug substance manufacturer, revealed two significant observations. The firm lacked adequate controls for computerized systems, specifically regarding user access and audit trail review for bag integrity testers. Additionally, laboratory controls were found inadequate due to a lack of individual identification and traceability for microbiological control plates used in bioburden testing.
- Company
- GlaxoSmithKline, LLC.
- Product type
- drugs
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ID · 427c278a-7412-4790-98d4-0aeb7758cc30
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