/ 1 min read / LexisNexis Practical Guidance

FDA Form 483: Inspection Observations & Responses

This video focuses on FDA Form 483, which is issued by FDA to US facilities and foreign facilities that are part of the US supply chain and products in the US manufacturer’s control. Under FDCA section 704, FDA is authorized to perform inspections of certain places, such as factories, warehouses, or establishments, where FDA-regulated products are manufactured, processed, packed, or held.

Authors

Cori Annapolen Goldberg
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