Difference between FDA 483 and Warning Letters
Difference Between FDA Form 483 and Warning Letter
1. FDA Form 483 (Inspectional Observations)
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Issued when: FDA inspectors observe potential violations of the Food, Drug, and Cosmetic Act (FD&C Act) during an inspection.
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Purpose: To notify company management of objectionable conditions observed.
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Tone: More of a preliminary finding; gives the company a chance to respond voluntarily.
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Response: Companies usually have 15 business days to respond with corrective actions.
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Impact: Not public until inspection is closed, but may lead to further action if not addressed.
2. FDA Warning Letter
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Issued when: FDA is not satisfied with the company’s 483 response or finds significant violations that pose risk to public health.
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Purpose: Formal notification that the company is in violation of regulations.
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Tone: Stronger, more serious, and demands corrective action.
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Response: Requires a detailed written response within 15 working days.
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Impact: Warning Letters are publicly posted on FDA’s website and can affect reputation, regulatory approvals, and business operations.
✅ In short:
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FDA 483 = List of inspectional observations (first step, not always public).
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Warning Letter = Escalated enforcement action (public, serious regulatory consequences).
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