Form 483
The list of objectionable conditions an FDA investigator hands you at the end of an inspection.
A Form 483 is the document an FDA investigator issues at the close of a facility inspection, listing observed conditions that may violate the Food, Drug & Cosmetic Act. It's not a final agency action - it's the investigator's observations - but it's the first formal signal something is wrong.
How you respond matters: a prompt, documented corrective-action plan can keep a 483 from escalating to a Warning Letter. The most common supplement 483 observation is failure to establish product specifications under 21 CFR 111.
Related terms
Guides that cover Form 483
The "Oh Crap, The FDA Is Calling" Guide to 21 CFR 111 Testing Requirements
FDA & GMPSupplement Finished Product Testing: The GMP Release Checklist
Compliance5 FDA Supplement Regulations You're Probably Violating Right Now
FDA & GMPFDA Warning Letters for Supplements -- Testing Violations
FDA & GMPForm 483 Response Guide for Supplement Companies
Amazon & MarketplaceGMP Certificate for Amazon -- Do You Need One?
Getting StartedISO 17025 vs Non-Accredited Labs: Why It Matters for Supplement Testing
Test MethodsMicrobial Limits Testing for Supplements
ComplianceSkip Lot Testing for Supplements — When You Can Reduce Testing
Getting StartedThird-Party Supplement Testing: Why It's Non-Negotiable
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