BLOOD & BIOLOGICS: 6886W

Allergy Labs, Oklahoma City, OK, Aug. 14 (Office of Compliance and Biologics Quality). FDA cited inadequate procedures to prevent the microbial contamination of purportedly sterile drugs, including deficiencies in the media fill procedure and water-for-injection (WFI) analysis; a lack of procedures addressing a manufacturing process used in repackaging, recalls, adverse event reporting, change controls and product changeover in production areas used for multiple products; an SOP that did not address corrective action following a sterility failure; non-adher-ence to the SOP stating the frequency of total particle counts; deficiencies in calibration, equipment maintenance, sterility testing, an incubator validation study, the WFI system design, component storage and the ventilation sys-tem; an unvalidated computer database and program used for tracking and distribution; failure to perform media growth promotion qualification and testing for the biological indicators= survival and kill time qualities; a lack of investigation or corrective action after a sterility test failure; incomplete review and approval of lab records; a lack of procedures for annual manufacturing operation reviews; and the failure to inform FDA about changes. The agency had not finished reviewing the company=s response to the 483. FDA acknowledged receipt of a letter ask-ing about the use of source material obtained from a particular supplier prior to the agency=s May 13 letter issued to all licensed allergenic product makers. The agency said it was the manufacturer=s responsibility to ensure that source material was collected and processed according to the regulations and establish appropriate procedures to determine acceptability. The company=s response was still under review, the letter said. FDA inspected the estab-lishment May 18-22.