FDA 483 OBSERVATION · #814 OF 1,000 MOST-CITED
FSVP assurances
FDA cited this observation 18 times across 18 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
How FDA worded it — real examples
Your FSVP did not provide adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide the required level of public health protection.
Your FSVP did not provide adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide the required level of public health protection.
Your FSVP did not provide adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide the required level of public health protection.
Your FSVP did not provide adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide the required level of public health protection.
Your FSVP did not provide adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide the required level of public health protection.
Your FSVP did not provide adequate assurances that your foreign supplier is producing the food in compliance with processes and procedures that provide the required level of public health protection.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.