Two medical device manufacturers of products intended to promote follicle growth and relieve pain are finding themselves in something of a hairy situation with the US Food and Drug Administration (FDA), according to two Warning Letters released on 20 August 2013.
The agency regularly releases Warning Letters, which act as official warnings of current and/or potential future regulatory actions, to serve as both an impetus to current companies to remedy violations and a deterrent to other companies who may be exhibiting similar behavior.
Too Close a Shave with the FD&C Act
The first Warning Letter was sent to Conair, a widely known manufacturer of hair care products. In this case, however, it was the company's Conair Heating Pad Model #HP01RB, intended to relieve pain, that was the focus on FDA enforcement efforts.
A May 2013 inspection of the company's Stamford, CT facility determined that the company's heating pads were adulterated because they were not manufactured in accordance with current good manufacturing practices (CGMPs) for medical devices under 21 CFR 820 (the Quality System Regulation, or QSR).
FDA inspectors noted a range of problems, including complaints that were improperly investigated. For example, several complaints were received with respect to third-degree burns, including one requiring specialized attention at a burn center and another requiring medical attention. In none of the cases did the company attempt to contact the complainant, FDA charged.
Worse, the company failed to adhere to FDA-mandated reporting regulations, which require those cases to be reported to the agency within 30 days of the company being made aware of a serious of deadly event. As a result of this lack of compliant, the heating device was also rendered misbranded.
The episodes were particularly concerning to FDA as it appeared that the device had malfunctioned-not simply been misused-resulting in the device sparking and catching fire. And because the company lacked a design control process or a written Corrective and Preventive Action (CAPA) process under 21 CFR 820.100(a), these problems seemed likely to continue.
Investigators said the company's response to an initial Form FDA 483 had not been received within the required 15-day response period (though it had been received), and was not reviewed "in-depth" for the purposes of the Warning Letter.
A second letter to Nashville, Tennessee-based Hair Labs international may have lacked the flame-induced burns of the Conair letter, but FDA inspectors highlighted similar problems in their letter to the device maker in a 9 August 2013 letter to the company, which manufacturers the AlphaLase LX50.
Among the complaints highlighted by FDA:
- an inadequate process for receiving and processing complaints
- no formal process for auditing the quality system under 21 CFR 820.22
- lack of validation of purchased equipment
- failure to establish CAPA procedures
- failure to establish a design history file (DHF) or maintain device master records (DMRs)
- management failures that resulted in a lack of "commitment to quality"
The takeaway from both letters, if there is one: Hair cells may be dead, but it's still the responsibility of the companies to make sure the patients don't end up that way by adhering to 21 CFR 820.
Warning Letter to Conair
Warning Letter to Hair Labs