FDA 483 - Inga Pharmaceuticals - June 12, 2017

Inga Pharmaceutical, a manufacturer in Tambaram, Chennai, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate instrument calibration, lack of label control procedures, and widespread failures within the quality unit regarding procedure adherence, scientific justification, and instruction specificity. The firm also lacked a defined sanitization frequency and failed to validate an Excel worksheet used for critical calculations.