FDA 483 OBSERVATION · #942 OF 1,000 MOST-CITED
Systems in place to comply with verification requirements
FDA cited this observation 15 times across 15 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 firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
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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