Devices

QS Violations in See Clear Inspection

A 10/21-11/4/16 FDA inspection at The See Clear Company, Norcross, GA, found violations of the Quality System Regulation in the firm’s work as a specification developer of soft contact lenses for daily wear under nine different brand names. A just-released 2/14 Warning Letter from the agency’s Atlanta District Office says that violations noted on an FDA-483 included:

failing to establish and maintain procedures for implementing corrective and preventive action;
failing to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
failing to establish procedures for acceptance of incoming product;
· failing to maintain distribution records;
failing to clearly define the type of extent of control to be exercised over contractors;
failing to adequately establish procedures to control product that does not conform to specified requirements;
failing to adequately maintain a device history record;
failing to document the dates of quality audits;
failing of management with executive responsibility to review the auditability and effectiveness of the quality system at defined intervals;
failing to document personnel training; and
failing to include in the documentation of approval of the documents, the approval date and signature of the approving official.

The letter acknowledges the firm’s 11/25/16 response that included a narrative response with a plan to complete corrections to address the inspection observations. The adequacy of the firm’s plan could not be determined, the District Office says, because the company did not include documents or evidence of the completion of its corrections.

See Clear was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken with an explanation of how it plans to prevent these or similar violations from occurring again, along with documentation of each step, and a timetable for completion.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome