Nomax Lands Warning Letter for Documentation, Other Violations
Nomax Inc. received a warning letter for failing to evaluate complaints, document corrective and preventive actions, and committing other violations.
The St. Louis, Mo.-based company manufactures and repacks contact lens cases and other products.
During an inspection of Nomax’s facility in October, the FDA discovered that the company failed to review, evaluate, and investigate quality complaints involving a container for soft, gaspermeable, and hard contact lenses. Nomax also failed to verify or validate corrective and preventive actions taken to address this complaint.
In addition, the FDA said Nomax did not review and document the suitability and effectiveness of its quality system at defined intervals. Specifically, the dates and results of management review meetings, including a list of attendees and review of quality trend analyses, were not documented from January 2015 to September 2016.
The agency also cited Nomax for not documenting acceptance activities for the contact lens container, including that the device conformed to width, depth, and other specifications.
The company additionally failed to maintain a device history record for the contact lens container and properly evaluate potential suppliers. The FDA also expressed concerns about the timeliness of training of key personnel and an audit that Nomax conducted of its products.
The FDA’s Quality System Regulation requires devicemakers to develop and maintain four files of information related to design, production and overall quality system. Order Device Documentation for a detailed guide that will help you understand each element and their relationships with each other, as well as guidance on how to develop the files.