Transdermal Cap produces the LaserCap, which uses light therapy to improve cellular respiration and stimulate hair follicle cells, the company claims. The device masquerades as a hat and can be worn underneath other hats, according to the company’s site.
During a facility inspection June 10, an FDA investigator issued a Form 483 detailing the company’s failure to conform to the agency’s requirements in a number of different categories.
Included in the complaint was a failure to establish standards for evaluating and reviewing complaints from customers, including 125 customer complaints that the federal watchdog said lacked dates and other information. The Agency said that a number of the complaints were not investigated, including cases where patients reported reactions of scalps burning, hair shedding and head itches.
The company was dinged for failing to establish procedures for creating corrective and preventive actions. The agency said that data sources were not being analyzed to identify product and quality issues, including changes to design based on complaints.
The FDA also warned on a failure in the company’s design control procedure for the design validation study of its LaserCap, according to the letter. The agency said there were no methods of acceptance criteria established, no documented date for the study and there was no documented assessment of the results of the survey that served as part of the study.
The warning letter also referenced failures to maintain risk analysis and a failure to establish and maintain supplier evaluations.