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This article was originally published in The Gray Sheet

Executive Summary

PACIFIC BIOTECH RETRAINING MANUFACTURING PERSONNEL as part of its response to a March 10 warning letter from FDA. Among several training deficiencies cited by the agency is "failure to follow written procedures" for the inspection of components of Cellulosenitrat Membrane and of HCG-Urine MS test kits. In its letter, FDA also points out that the firm failed to follow standard operating procedures (SOPs) for stability testing and expiration date testing for certain lots of Strep A O.S. products. The firm's response to this citation, which was communicated earlier in an FD-483 list of adverse observations, "is inadequate," FDA says. "The issue relates to following your SOPs, not to whether the reliability of the final results were affected." FDA inspected the in vitro diagnostic manufacturer's San Diego facility between Dec. 14 and Jan. 28. In addition, the warning letter notes a "failure to establish processing controls in the Multi-Step facility to assure that deviations from device specifications do not occur in that negative production controls were found by customers in HCG- Urine Test Kits." FDA says that Pacific Biotech provided neither a copy of its new procedure nor "documentation indicating training procedures and verification that training occurred" in its response to the 483. Pacific Biotech, a subsidiary of Eli Lilly, responded to FDA's letter on April 2. The firm says it also is revising its finished device testing and record-keeping procedures in order to correct other violations cited in the warning letter. FDA says that the firm has failed to "test finished devices for conformance with device specifications prior to release for distribution." Specifically, no such testing was performed on Cards O.S. Strep A tests, according to the agency. The letter also states that certain "Master Batch Records for Strep A O.S. Low Sensitivity controls" were unavailable during the FDA inspection and that "no protocol or test data for extending the expiration date of the Strep A O.S. Test Kits from nine to twelve months was available." The agency's inspection followed two December recalls of the Cards O.S. and Concise Strep A test kits, which were exhibiting false positive results. The firm says that both recalls are nearly complete. Pacific Biotech also conducted two recalls in August that involved several different types of tests including the Cards O.S. HCG-Urine and Strep A tests and the Concise HCG-Urine and Strep A immunochromatographic assays.

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