21-item 483 leads Lee Laboratories to cease business.

Lee Laboratories, Ponca City, OK Dallas District

A manufacturer of dental headgear, Lee Laboratories chose to cease business "rather than try to comply with all of the required filings," the company wrote, after an FDA inspection identified 21 violations of GMP requirements.

The firm later confirmed that it had completely closed its business as of March 3, 2007.

Investigator Margaret Ames cited the firm for failure to implement a complete quality system "as evidenced by the lack of a quality policy, lack of written procedures, failure to conduct quality audits and failure to conduct management reviews of the quality system." Lee Laboratories also failed to develop a written quality plan defining the company's quality practices, resources and activities and how quality requirements would be met.

These observations, among several others, were repeat observations from an FDA inspection conducted Aug. 9-11, 2004.

The firm had no written procedures for conducting quality audits or management reviews of the quality system, and had not conducted any audits or reviews, Ames reported.

Lee Laboratories also neglected to develop procedures for acceptance or rejection of finished devices. The firm had "a Final Acceptance Checklist that has not been reviewed or approved, and there are no written procedures for completing the form," Ames wrote. "The firm has not defined in writing what manufacturing specifications and acceptance criteria have to be met and the inspection, tests and verification activities that are to be performed."

The firm also had no procedures for acceptance or rejection of incoming product, Ames stated. "The firm has an Acceptance Sheet for Received Goods that has not been reviewed and approved and has no effective date. There are no instructions for filling out the sheet, no written specifications for the incoming product to verify that the product meets those specifications and no procedure for defining how product is rejected," she wrote.

The company had no procedures for handling nonconforming materials, no written procedures for complaint handling, and no purchasing control procedures, Ames observed. "The firm also does not have any written procedures describing the qualification and approval of vendors or a requirement for documented evaluations." Neither did Lee Laboratories have written and approved specifications for any of its components, Ames added.

The firm did not have a complete Device Master Record, the investigator wrote. There were no written specifications for components or finished product, and no written procedures describing testing and inspection activities for acceptance and rejection of components and finished product. The Device History Record did not include manufacturing dates for each work order.

Lee Laboratories had no procedures for implementing and documenting corrective and preventive action, and no procedures for document control, Ames noted. The quality system documents the firm had developed had not been signed or dated to document review and approval and effective date.

The company had no written procedures for identifying incoming components and products and following those components from receipt through manufacturing and distribution of finished product, Ames stated. Nor did Lee have any written procedures describing how headgear were to be labeled, or for the control, review and approval of labeling.

Ames observed that the company had no written procedures for the control and distribution of finished product to ensure that only devices approved for release had been distributed.

Lee Laboratories, 9/25-27/06, Doc. 110103, $20 plus retrieval