Bioburden tests, cleaning detain Wembley gloves.

Wembley Rubber Products, Selangor, Malaysia.

Cleaning issues remained a problem when FDA reinspected latex glove manufacturer Wembley Rubber Products, whose goods were placed on automatic import detentions twice before the audit occurred.

Ironically, FDA made note in the EIR that Wembley was "the first locally owned Malaysian firm to become certified by the British Standards Institution and registered in the U.K."

When investigator Sharri Yoder, then with the Dallas district, arrived in March 1997, cleaning deficiencies were still a problem, along with quality issues. A 1995 audit found the company out of step with FDA's expectations for bioburden testing, cleaning and training, among other areas (See August 1996 issue, page 7).

Yoder: Don't rely only on testing

The first of Yoder's 15 observations on the 483 showed that FDA was not willing to accept tighter test requirements as a substitute for built-in quality controls.

She noted a surge in non-conformance notices (NCNs) regarding thin spots, with no re-sulting design analysis, investigation or change in procedures.

Management explained that the increase in NCNs followed its response to the two detentions. The company had reclassified thin spots from a minor to a major defect, increasing the level of screening and, therefore, the number of reports, according to the EIR.

Yoder answered that "a quality system should not solely try to test products to determine compliance, it should design desired quality attributes into the product." She then reeled off nine more deficiencies that may have contributed to the quality problems:

* No record of investigating contamination of equipment to form gloves (called "formers") and discrepancies in the cleaning checklist.

* Failure to clean glove formers that were stored outside in tubs with open gratings, exposed to environmental contaminants.

* Tubs that were stacked in a way that might damage formers.

* A lack of detail in cleaning procedures.

* Unvalidated cleaning procedures.

* Failure to adhere to the cleaning schedule.

* Non-adherence to the procedure that required documenting conclusions and follow-up actions on NCNs before closing out investigations.

* Incorrect and incomplete data in records of cor-rective actions taken in response to complaints.

* A lack of specifications in a procedure for trial dipping after cleaning formers.

Yoder reminded management that the reason for cleaning the formers was to prevent quality problems resulting from dirty formers, a problem documented in the conclusions of some complaints Wembley had received.

Further concerns involved inconsistencies between formal and informal clean-room proce-dures for handwashing, incomplete pest control reports, failure to evaluate environmental challenges, failure to perform the control for the powder-content test and inconsistencies in packaging records.

Despite continued problems, there is no record that the 483 yielded a warning letter.

Wembley Rubber Products, Selangor, Malaysia, 3/9-13/95 and 3/3-7/97, Doc. 108329M, $11 plus retrieval.