483
Ultragenyx Pharmaceutical Inc.FDA 483 - Ultragenyx Pharmaceutical Inc.
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Record Details
Ultragenyx Pharmaceutical Inc. in Bedford, MA, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate quality oversight leading to errors in Master Batch Records, insufficient acceptance criteria, and manufacturing spaces not adequately cleaned. Additionally, the firm failed to follow written production and process control procedures.
- Product Type
- Drugs
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ID · 9a6da5b4-ae5a-41d0-8b0b-bfd9a0b63889