FDA 483 OBSERVATION · #157 OF 1,000 MOST-CITED
Evaluation of suppliers, contractors, etc., requirements
FDA cited this observation 150 times across 144 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
Requirements that must be met by suppliers have not been adequately established.
Requirements that must be met by suppliers have not been adequately established.
Requirements that must be met by suppliers, contractors and consultants have not been adequately established.
Requirements that must be met by suppliers, contractors and consultants have not been adequately established.
Requirements that must be met by suppliers and consultants have not been adequately established.
Requirements that must be met by suppliers and contractors have not been adequately established.
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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