Laser hair removal company cited for cGMP violations
FDA inspector badges at its headquarters in White Oak, MD. (Source: Ferdous Al-Faruque)

The US Food and Drug Administration has warned New Jersey-based laser hair removal company EpiCare for failing to meet current good manufacturing (cGMP) requirements and maintaining procedures to submit medical device reports (MDR).

In a 21 March warning letter, FDA said EpiCare, manufacturer of the EpiCare-Zenith laser systems, had failed to meet several regulatory requirements. The citations include failing to maintain procedures for validating the device design; procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, and procedures for implementing corrective and preventive action (CAPA). The company was also cited for failing to maintain device history records (DHR) and device master records (DMR) and not establishing procedures for identifying training needs.

“There is no evidence that a validation was performed to demonstrate that the EpiCare-Zenith Laser System’s (all models) hardware will consistently perform as intended when attempting specified treatment optimization parameters (wavelength, handpiece spot size, pulse duration, pulse fluence, pulse rate, and operating mode (continuous or countdown mode with number of shots to be delivered) under actual or simulated conditions, including challenging conditions such as procedures with [redacted] and [redacted] settings,” said FDA. “There is also no evidence that a validation was performed under defined operating conditions (actual or simulated) on initial production batches or equivalents for each of the EpiCare-Zenith Family of Laser Devices.”

The warning letter came after FDA inspected EpiCare’s facilities in November and December of last year. After the company was initially told of the problems discovered by inspectors, it provided responses that the agency said were inadequate.

In response to the lack of design validation for instance, FDA noted that EpiCare submitted an undated document entitled “Clinical Literature Review.” However, the agency said the document was a compilation of clinical literature summaries of products similar to its products but did not include any literature review of the products it manufactures.

FDA also cited EpiCare for failing to have Compliant Electronic Product Radiation Control (EPRC) labeling and not having adequate written MDR procedures.

During the inspection, FDA said EpiCare provided inspectors with a document entitled “Medical Device Records and Product Recalls.” However, the agency said the document failed to establish proper internal systems to ensure incidents are timely, effectively communicated, and evaluated. According to inspectors, the company’s procedures also failed to transmit complete MDRs promptly.

EpiCare was also cited for noncompliant labeling and failing to submit information to the Global Unique Device Identification Database (GUDID) as required by regulations.

“FDA has determined that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label,” said FDA. “EpiCare Acquisitions, LLC. is therefore a ‘labeler’ … and has not submitted to GUDID any information required by [regulation].”

While EpiCare promised to register its laser systems with GUDID, FDA said the products had not been entered into the system as of the date of the warning letter.

FDA gave EpiCare 15 business days to respond to the warning letter