Access to Records

MoCRA: This information is applicable to: All Cosmetic Manufacturers

Under the new MoCRA requirements, the FDA now has the authority to access all your records regarding a cosmetic product if they have a reasonable belief that the product could be harmful or that use or exposure to the product could result in serious harm.¹

This is new; before MoCRA the FDA could request to see the records during an inspection, but it couldn’t make the company do it (like they could for drugs, food or dietary supplements).

Who can see the records?

You have to show the records to an FDA "duly designated officer or employee" if they show you appropriate credentials and a written notice. You must give them access to see and copy records at a reasonable time and in a reasonable manner.

What records can they see?

The inspector can look at your records for the cosmetic product(s) they are investigating, and any other products they think are likely to be similarly affected. They can look at whatever they think will help them determine if the product(s) are, in fact, adulterated or a health risk. Generally, that would be likely to be things like your batch records, information about the ingredients used, storage of the materials and ingredients (so they didn’t become dirty or contaminated), safety substantiation data, qualifications of people doing the work, and information about where the products may have been shipped. They can make copies of all those records as well.

They don’t have the right to look at or copy recipes or formulas for cosmetics, financial data, pricing information, research data (other than safety substantiation data for the products and ingredients), personnel data (other than regarding the qualifications of technical or professional personnel), or sales data (except shipping data).