FDA 483 - DPT Laboratories Ltd - May 01, 2014
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An FDA inspection of DPT Laboratories, Ltd in San Antonio, TX, revealed significant deficiencies across packaging, labeling, and laboratory controls. Observations included a lack of and failure to follow written procedures for material handling, inadequate security for labeling materials, and contamination risks from improper gowning. Furthermore, the firm's laboratory controls were found to be deficient, with issues in test procedures, data integrity, and the investigation of unexplained discrepancies.
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- Dallas District Office
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ID · 9641550e-2386-44d6-bb5a-2bd00a8253a8