FDA inspection glossary

Response to a Form 483

A 483 response is the firm's written reply to the observations on a Form 483, usually describing corrective actions and timelines.

Recommended, not required. Firms aren't required to respond. FDA recommends responding within 15 business days and considers responses when deciding on further action [1][2].

On FDA Intel

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Sources

FDA guidance document
fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-basics/inspection-classifications

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