Cipla Limited announced the conclusion of a routine Current Good Manufacturing Practice (cGMP) inspection conducted by the United States Food and Drug Administration (US FDA) at its manufacturing facility located in Pithampur, Madhya Pradesh.
The inspection concluded with the US FDA issuing a Form 483 containing seven procedural observations. The audit focused on evaluating standard operating procedures, quality control systems, and regulatory compliance protocols across the plant’s production lines.
Cipla is thoroughly reviewing the observations and is preparing a comprehensive Corrective and Preventive Action (CAPA) response. The company will submit its detailed response to the US FDA within the stipulated 15-business-day timeframe and is committed to working closely with the regulatory agency to address all highlighted items promptly.
”Quality and regulatory compliance remain the foundational pillars of Cipla’s global operations,” the company said in a statement. “We view continuous regulatory feedback as a vital component of maintaining highest-in-class manufacturing standards.”
The Pithampur unit is a strategic site supporting Cipla’s global portfolio. The company does not anticipate any immediate disruption to product supplies or commercial operations and maintains full commitment to delivering safe, high-quality medicines to patients worldwide.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
