FDAsafety guidance95% confidence
Prime Food Processing LLC Issues Safety Warning Regarding Uneviscerated “Dried Herring Fish”
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to FDA Issues Guidance on Postapproval Pregnancy Safety Studies; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Brooklyn, NY – Prime Food Processing LLC is voluntarily recalling 69 cases of “Dried Herring Fish” because the product was not adequately eviscerated.
Supporting Context
- Therapeutic area
- General · Drug Safety
- Sub-indication
- General
Related signal: FDA Issues Guidance on Postapproval Pregnancy Safety Studies