In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa Capote, an FDA compliance attorney. If you’re a cosmetic manufacturer, FDA inspections are now a bigger reality thanks to the Modernization of Cosmetics Regulation Act — MoCRA.
Under MoCRA, the FDA has enhanced inspection authority over cosmetic facilities. The FDA can now inspect cosmetic manufacturing facilities to verify compliance with Good Manufacturing Practice requirements, safety substantiation, adverse event recordkeeping, and facility registration and product listing obligations.
Here’s what to expect during an FDA cosmetic inspection. Investigators will review your GMP practices — your facility cleanliness, equipment maintenance, quality control procedures, and batch records. They’ll look at your adverse event records to confirm you’re capturing and reporting serious adverse events within the required 15-business-day window. They’ll verify that your facility is properly registered and your products are listed.
Documentation is key. You need written procedures — SOPs — for your manufacturing processes, and you need to follow them consistently. If it’s not documented, it didn’t happen.
The best approach to FDA inspections is preparation. Conduct regular internal audits, train your team, and make sure your documentation is organized and current before an investigator walks through the door.
We help cosmetic manufacturers prepare for FDA inspections and respond to 483 observations. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.