FDA 483 OBSERVATION · #480 OF 1,000 MOST-CITED
Acceptance of drug products
FDA cited this observation 39 times across 38 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
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
Determinations of conformance to appropriate written specifications for acceptance are not made and deficient for drug products. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Determinations of conformance to appropriate written specifications for acceptance are not made for drug products.
Determinations of conformance to appropriate written specifications for acceptance are not made for drug products.
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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