The QMN Weekly Bulletin
Quality / Medical Devices

FDA Warns See Clear Company for Record-Keeping Problems

June 23, 2017

The FDA issued a warning letter to contact lens manufacturer The See Clear Company, citing problems with its complaint and corrective action procedures.

The agency conducted an inspection of the company’s Norcross, Georgia, facility during October and November and issued a Form 483. Although See Clear promised to correct these problems, the agency has no way to determine whether the company’s efforts have been effective, and the company response did not include documentation of corrections it made.

The initial inspection found the company’s corrective and preventive action procedure does not include verifying and validating corrective actions or recording changes in the procedure. The FDA also faulted the company’s complaint procedure, noting that it does not cover how to determine when investigations are necessary or appropriate methods of handling customer complaints or maintaining complaint files.

The firm also had no established procedures for accepting incoming products or documenting acceptance or rejection, according to the warning letter, and the facility could not provide complete distribution records or define the firm’s control over contractors. The company’s written procedures for nonconforming products do not reflect current practices, and the firm could not provide complete device history records for one lot of its Diamond Brand soft contact lenses.

The company also failed to document personnel training as well as the dates of both quality audits and approval documents, and the company’s management was unable to provide dates, agendas and attendance records for 2014 and 2015 review meetings, according to the FDA.

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