- 1. Qingdao’s quality unit failed to have the appropriate system and procedures to provide confidence that the drugs manufactured at the facility met the intended specifications for identity, strength, quality and purity.
- 2. Qingdao failed to conduct and document regular product quality reviews for the drugs produced that would include at a minimum, a review of critical in-process controls and test results; review of all batches that failed to meet the established specifications; and investigation of process deviations and complaints to ensure the product remains within specifications and that corrective actions had been implemented.
- 3. Qingdao failed to investigate specific discrepancies related to the lots of impure drugs supplied to its customers. The FDA learned that heparin sodium lots manufactured at Qingdao’s facility were determined to be contaminated with OSCS. At the time of the inspection, no investigation had been conducted into this repeated and unacceptable contamination.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
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