For biotech and biologics teams
Your first FDA inspection doesn't have to be a surprise.
See what FDA investigators write up at biologics sites and contract manufacturers, and check your CDMO's record before your launch depends on it.
Learn from the sites that went first.
Many biotech teams meet an FDA investigator for the first time at a pre-approval or pre-license inspection. The Form 483s written at other sites show what investigators look for, in their own words.
See how findings are written
Read real observations on contamination control, aseptic processing and process validation.
Check your CDMO
Search a contract manufacturer by name or FEI number and read its 483s and warning letters before you rely on the site.
Follow a site over time
See how a 483, the firm's response and any later warning letter or close-out fit together.
Get ready for your first inspection
A first pre-approval inspection is the one to prepare for properly. Start with a report from our team, then read the documents that matter.
Custom report · best fit
A report from our team
We review your CDMO's and your own sites' records, the investigators likely to come and what FDA cites at biologics sites, and give you a written brief before the inspection.
Priced per project
Request a custom reportDocuments
The original documents
Read biologics 483s and your CDMO's complete record: every 483, warning letter and close-out we hold for the site.
From $99 per document
Browse documentsYour approval can depend on a site you don't run.
Check the inspection record of every site named in your application.
How biotech teams use FDA Intel
Read the site's record
Every 483, warning letter and close-out for the FEI number.
Study similar sites
Recent biologics 483s show the themes investigators raise most.
Keep the precedents close
Have FDA's own wording on hand when a topic comes up.
What FDA cites most in biologics 483s
Share of biologics Form 483s since 2023 that cite each CFR section at least once.
See all regulationsStart with your product type
Open recent Form 483s for sites that make what you make.
Questions
What is a pre-approval inspection?
An FDA inspection linked to a pending marketing application. FDA checks that the site can make the product as described in the application. It often happens at the site that will make the product, which may be a contract manufacturer.
How can I check a CDMO's inspection history?
Search by the contract manufacturer's name or FEI number. The firm page lists its Form 483s, EIRs, responses and warning letters in date order. Buy the documents your qualification needs.
Is an FDA Form 483 a violation?
No. A Form 483 lists observations made during an inspection. It is not a final agency decision. Read it with the EIR and any 483 response to understand the full picture.
Do I need a subscription?
No. Documents are bought one by one, with no subscription. Custom reports are priced per project.