FDA 483 OBSERVATION · #333 OF 1,000 MOST-CITED
Supplier notification of changes
FDA cited this observation 62 times across 62 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
There is no agreement with suppliers to notify you of changes in the product or service.
There is no agreement with suppliers and contractors to notify you of changes in the product or service.
There is no agreement with suppliers and contractors to notify you of changes in the product or service.
There is no agreement with suppliers to notify you of changes in the product or service.
There is no agreement with suppliers, contractors and consultants to notify you of changes in the product or service.
There is no agreement with suppliers to notify you of changes in the product or service.
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.
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