483
Teligent Pharma, Inc.FDA 483 - Teligent Pharma, Inc. - March 08, 2011
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An FDA inspection of IGI Inc., a drug manufacturer in Buena, NJ, revealed significant deficiencies in employee training and experience. The firm's manufacturing compounders were involved in numerous processing deviations due to operator error, and previous corrective actions were found to be ineffective. This indicates a systemic issue with personnel qualifications and quality control in drug product manufacturing.
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ID · 77c7b0e4-7e1a-4f33-a08b-2893e810f8c1