Details bedevil maker of compression garments.

Beiersdorf-Jobst, Toledo, OH, Cincinnati District

Cleaning validation was FDA's chief concern involving a 1999 audit of Beiersdorf-Jobst's Toledo, OH, compression garment manufacturing facility.

Mary Kay Concannon of the Chicago district paired up with Lori Lahmann of the Cincinnati district for an audit of the firm, inking in seven deviations. The company's management decided not to annotate the 483 other than to indicate its intent to write the district regarding the findings.

FDA did not release the company's reply to the audit, but an April 6, 1999, warning letter (Doc. 7503W) repeated each 483 citation, noting Beiersdorf's response was inadequate. While FDA did not address each of the company's responses individually, the letter did recommend that Beiersdorf acquire certification by a consultant, a move perhaps spurred by the similarity between the 1999 findings and those from a 1992 audit that FDA indicated also resulted in a warning letter.

Concannon and Lahmann referred in the EIR to past problems, including a patient who experienced necrosis of the leg, and subsequent amputation of a limb, in connection with a Beiersdorf device that appeared to be unrelated to sterile garments made in Toledo. Beiersdorf later stopped making the device. Lahmann also referred to a 1994 inspection, but FDA purged that audit's classification. Beiersdorf-Jobst is a subsidiary of Beiersdorf AG, of Hamburg, Germany.

The 483 alleged Beiersdorf-Jobst failed to validate use of a scrubber and cleaning agent to remove fabric residues from a laser knife holding bed. Lahmann wrote that there was a validation procedure during the audit, but the protocol never addressed residue removal.

Lahmann stated that the existing validation covered the laser speed and wattage, described as the "most critical aspects of the process and the ones that may vary." However, the FDAer was not pleased to observe the firm's personnel "cut the fabric with the laser with this residue" on the stainless steel cutting bed.

The EIR stated that the area manager of the cutting department, Cheryl Bates, informed Lahmann that Beiersdorf used a floor scrubber and household cleaner "409" to clean residues, but the company had neither a schedule for cleaning nor documentation as to "the last time the laser bed was cleaned."

Lahmann's concerns were prompted by an unspecified number of complaints involving skin irritation or "breakdown" and she Asked Quality Assurance Manager Andrew Betz whether the company had any documentation addressing the possibility that the residues may have contributed to the reports. Betz admitted he could not answer inasmuch as the issue had not found its way into the initial validation "or any subsequent studies."

The Cincinnati district cut the firm no slack in the warning letter, either. FDA wrote that the firm's response to the 483 indicated the cleaning procedure would be validated, but did not say how. The agency also inquired as to the firm's intent regarding use of a standard and the proposed time for completion of the work.

Cleaning schedule not 'conducive' to operations

The laser cutter was nearly as central to Lahmann's inspection as it probably was to Beiersdorf's operations. The following citation on the 483 hammered the company for failure to follow the manufacturer's recommended cleaning schedule for the laser cutter's exhaust head.

According to the EIR, the exhaust head was "located directly adjacent to the laser head" and drew away smoke bred during cutting operations. Steven Spencer, the company's manager of garment manufacturing, indicated that when the exhaust head lacked sufficient vacuum, exhaust gases would be pulled across the fabric into holes in the stainless steel bed by suction generated to hold the fabric in place. Spencer added that the resulting dots in the fabric constituted an in-process failure, necessitating rework of the item.

FDA purged the name of a document that called for daily cleaning of the exhaust head.

Lahmann noted that between May and October 1998, the firm cleaned the exhaust head 50 times and that between July 7, 1998 and Feb. 26, 1999, the firm conducted maintenance work on the laser 92 times "in conjunction with the exhaust equipment leaving dots, smoking at the laser head and removing fabric from the laser head."

Lahmann cornered Spencer on the matter, who evidently stated that the firm decided that a daily cleaning schedule was "not conducive" to their manufacturing operations.

The district office stated that Beiersdorf's response indicated it had revised the exhaust head cleaning procedure to reflect an "as needed" approach, suggesting that cleaning would not take place until in-process failures appeared. FDA asked whether its impression was "correct."

Lahmann noted in the 483 that Beiersdorf lacked procedures for corrective and preventive action along with documentation of such actions for 54 in-process failures. Betz insisted that the corporate-wide procedure for failure investigations covered the issue, but Lahmann complained that the procedure did not cover in-process failures involving scrapped cuts of fabric.

According to the EIR, the only documentation available for such events were some "rework" sheets and Lahmann noted several trends, including dotting and short fabric cuts. However, she was unable to locate any available documents covering corrective and preventive action and the firm's personnel were likewise empty-handed.

The warning letter addressed the firm's proposed corrections but asked when Beiersdorf would implement the procedure and whether the procedure would deal with in-process problems.

Attempts to contact the firm for an update were unsuccessful.

Beiersdorf-Jobst, Toledo, OH, 2/22-3/3/99, Doc. 109023M, $19.00 plus retrieval.