FDA 483 OBSERVATION · #705 OF 1,000 MOST-CITED
Good compliance standing
FDA cited this observation 23 times across 23 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
You did not document whether the foreign supplier of a food you imported is in good compliance standing with the food safety authority of the country in which the foreign supplier is located.
You did not determine and document whether the foreign supplier of a food you imported is in good compliance standing with the food safety authority of the country in which the foreign supplier is located.
You did not determine and document whether the foreign supplier of a food you imported is in good compliance standing with the food safety authority of the country in which the foreign supplier is located.
You did not determine and document whether the foreign supplier of a food you imported is in good compliance standing with the food safety authority of the country in which the foreign supplier is located.
You did not determine and document whether the foreign supplier of a food you imported is in good compliance standing with the food safety authority of the county in which the foreign supplier is located.
You did not document whether the foreign supplier of a food you imported is in good compliance standing with the food safety authority of the county in which the foreign supplier is located.
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.