FDA 483 - Pacira Pharmaceuticals, Inc. - April 19, 2023
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An FDA inspection of Pacira Pharmaceuticals, Inc. in San Diego, CA, a sterile manufacturer of human and animal drugs, revealed two significant issues. The firm failed to thoroughly investigate unexplained discrepancies and out-of-specification results, and did not adequately implement corrective and preventative actions. Additionally, records for calibration checks and equipment inspections, specifically cleanroom certification, were found to be deficient with individual measurements exceeding limits.
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