483
GlaxoSmithKline dba Human Genome Sciences IncFDA 483 - GlaxoSmithKline dba Human Genome Sciences Inc
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Record Details
Human Genome Sciences, Inc. in Rockville, MD, a drug substance intermediate manufacturer, received a Form 483 with three observations. The inspection revealed issues with the manufacturing process, including undocumented repeated steps and non-conforming batch numbering. Additionally, the firm failed to follow written procedures for deviation reporting and investigation, and employees were not adequately trained prior to performing manufacturing operations.
- Product Type
- Drugs
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ID · 06180595-cb3e-4947-86f4-5a753f6134fb