FDA 483 OBSERVATION · #630 OF 1,000 MOST-CITED
Allergen Controls Corrective Action Proced: Estab Implement
FDA cited this observation 27 times across 25 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 establish adequate written corrective action procedures for allergen controls.
You did not establish adequate written corrective action procedures for allergen controls.
You did not establish adequate written corrective action procedures for allergen controls.
You did not establish and implement adequate written corrective action procedures for allergen controls.
You did not establish adequate written corrective action procedures for allergen controls.
You did not implement adequate written corrective action procedures for allergen controls.
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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