Did you think that the FDA only visits or inspects the big pharma companies or food manufacturers? Not so much. No facility that uses FDA-approved medical devices or distributes pharmaceuticals or cosmetics is too small for an FDA visit, MedSpas and Wellness Centers included.
Here's more information regarding what might bring FDA to your doorstep, and what you should have on hand when they arrive.
Do you sell or administer cosmetic, pharmaceutical, dietary supplement or nutraceutical products?
Many in the Aesthetic and Wellness industries sell privately-labeled cosmetic creams, lotions, Botox, fillers, vitamins, supplements or nutraceutical products. Your center might even administer one or more of them to patients/customers.
The Federal Food, Drug, and Cosmetic Act (FDCA) and Modernization of Cosmetics Regulation Act (MoCRA), however, provide that a facility that sells or administers drugs (Botox, fillers and items containing sunscreen ingredients), distributes food products (vitamins, supplements and nutraceuticals) or sells or distributes cosmetic products under its own label may be subject to inspection of its facilities and records for compliance with FDA laws and regulations.
Do you use FDA-approved medical devices such as cosmetic or therapeutic lasers, cryogenics or surgical tools?
Cosmetic and medically-adjacent procedures represent a large segment of the Aesthetic and Wellness industries. These procedures often require use of FDA-approved medical and/or cosmetic devices such as lasers, cryogenics, hydrotherapy and surgical tools. Like hospitals, MedSpas and Wellness Centers are not subject to routine FDA inspection simply because such equipment is located and used in their facilities.
FDA, however, will conduct investigations of therapeutic and cosmetic facilities upon:
1. Report of an adverse event due to misuse of a medical or cosmetic device at that facility
2.Report of a facility using an unapproved medical or cosmetic device, or
3. Report that the facility is acting as a device manufacturer by relabeling or changing devices, such as by filling multiple syringes from what was marketed by the manufacturer as a single syringe product.
What do you need on hand in your facility should the FDA ask to inspect your facility or records?
Both the FDCA and MoCRA set requirements for what information a MedSpa or Wellness Center needs to have on hand based on what treatments the facility sells, uses or administers.
- If the facility sells or administers pharmaceutical or food products, it must have on hand information sufficient to identify the sources of such products and any reports of adverse events that may be related to administration of those products to the facility’s patients/customers, including any information regarding medical treatment or follow-up from such adverse events.
- If the facility sells or administers cosmetics, it must have records of all adverse events related to sale or administration of such products, as well as medical backup for any serious adverse event (i.e., death, permanent disfigurement or injury requiring significant medical intervention).
- If the facility provides treatments using medical or cosmetic devices, then it must have on hand documents substantiating that the device is in proper working order and records of any adverse events related to treatments using the device at the facility within its knowledge.
What should you do if the FDA does arrive at your facility asking to inspect your premises or record?
First, and foremost, be polite and do not cause a confrontation.Ask the agent or representative for identification and contact information. Upon presentation of identification and contact information, make a record of the information and request the agent or representative provide an explanation for the visit.
After receiving any additional information, request the agent or representative return at a later date after you have had an opportunity to speak with your attorneys. After the agent or representative leaves, contact legal counsel with any information you were able to gather.
The authors and the FDA regulatory team at Buchanan have significant experience counseling MedSpas and Wellness Centers on FDA requirements and navigating FDA inspections and other actions. Should you have a question or a situation arise at your facility, they stand ready to assist with you with resolving your issues. FDA & Biotechnology Lawyers | Buchanan Ingersoll & Rooney PC
