Glossary
Risk
The combination of the probability of harm occurring and the severity of that harm.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You failed to adequately test each shipment of each lot of propylene glycol for identity, a component at higher risk for diethylene glycol (DEG) and ethylene glycol (EG) contamination.
FDA · FDA Warning Letter · 2024-09-24 -
For example, your firm failed to adequately test each shipment of each lot of incoming components at high-risk of diethylene glycol (DEG)…
FDA · FDA Warning Letter · 2024-04-16 -
There are currently no tests that can evaluate a donor’s risk for CJD or xenotransplantation.
FDA · FDA Warning Letter · 2024-10-22
