Beiersdorf cleaning validation leads to QA consultant request.

Beiersdorf-Jobst's "Quality Review Board" and commitments on cleaning validation were the subject of an April 6 warning letter, which followed an inspection Feb. 22-26 and March 1-3 of the firm's Toledo, OH, plant.

Specifically, the Charlotte, NC-based company was cited for allegedly failing to validate the cleaning system for an unidentified manufacturer's "Cutting Edge Laser" fabric holding bed to remove laser cut residues.

The agency acknowledged Beiersdorf's March 16 response to the 483, but replied with additional comments and questions. FDA found that neither the SOP for quality review by the board nor the SOP for failure investigations was "implemented in association with re-cuts of fabric due to in-process non-conformities."

The firm's response also indicated it would add more definition and create a more-detailed procedure for its corrective and preventive action SOP. FDA asked in the warning letter: "When is this to be drafted and/or implemented? Will this procedure address in-process non-conformities? Will it include 'triggers...for internal failures related to the laser cutting system?'" FDA then noted Beiersdorf-Jobst's "Quality Review Board" initiated a project to perform an in-depth investigation of internal failures coming from the laser cutting operation." The agency asked: "What is the projected time frame for implementation?"

FDA poses validation questions in letter

Responding to the firm's assertion that its cleaning procedure will be validated, FDA queried: "How? Will you use a standard? When are you planning to conduct this validation study?"

Finally, the agency observed that the response indicated the firm revised its laser exhaust head cleaning procedure to an "as needed" basis. "This suggests that the cleaning will not be conducted until in-process failures appear (i.e. "dots" appearing on the compression garment fabric during cutting from the laser exhaust being pulled through the fabric and the holes in the cutting bed). At this time (when "dots" appear on the fabric), the laser exhaust head will be cleaned. Is this correct?" FDA asked.

The agency said similar GMP deviations were cited in an Aug. 4, 1992, warning letter and a May 26, 1993, audit.

FDA requested that the firm submit to an audit of its manufacturing and quality assurance systems by an outside expert consultant and submit the consultant's report before the agency would render a determination that corrections were made.