Cipla’s InvaGen Facility Receives Two USFDA Observations After Inspection

Pharma major Cipla Ltd. has disclosed that the United States Food and Drug Administration (USFDA) recently completed a routine current Good Manufacturing Practices (cGMP) inspection at its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc., located in Hauppauge, Long Island, New York.

The inspection, which covered Units 1 and 2 of the facility, concluded with two inspectional observations. Cipla emphasized that it is preparing a comprehensive response to the regulator and remains committed to maintaining the highest standards of manufacturing quality and compliance.

Key Highlights

• Inspection Details: Conducted by USFDA at InvaGen’s Hauppauge facility.
• Outcome: Two Form 483 observations issued.
• Cipla’s Response: Company to submit corrective action plans addressing the observations.
• Commitment to Compliance: Cipla reiterated its focus on regulatory adherence and global quality benchmarks.
• Business Impact: While minor observations are common in inspections, timely resolution is critical to avoid supply chain or approval delays.

This development underscores Cipla’s proactive approach to regulatory compliance and its continued focus on strengthening trust with global healthcare stakeholders.

Sources: Cipla Exchange Filing, The Health Master, Moneycontrol