Unannounced US FDA inspection at Lambda’s Ahmedabad facility concluded successfully with zero Form 483 observations. The inspection was conducted from 27 April to 01 May 2026. Conducted from 27 April to 01 May 2026, the inspection covered the bioanalytical phase.
Inspection Details:
- Facility Inspected: Lambda Therapeutic Research, Ahmedabad
- Scope: Bioanalytical (4 studies)
- Outcome: No Form 483 Observations
Lambda received appreciation for:
• Clean and well-organized laboratory areas
• Digitized sample management and data review systems
• Robust and reliable data workflows
• Clarity and accuracy of records
This outcome reinforces Lambda’s continued focus on global regulatory compliance, data integrity, and operational excellence across its bioanalytical operations.
We remain focused on upholding global regulatory standards to support the development of safe and effective therapies for our clients and their patients. For more information about our full-service CRO Capabilities and regulatory track record, please contact us at bd@lambda-cro.com.
About Lambda
Lambda & Novum delivers full-service CRO services to the innovator, biotech, and generic pharmaceutical industries worldwide. With a strong global presence in India, the USA, Canada, the UK, Spain and Poland, we bring specialized expertise to every project. Our focus on secure IT infrastructure and automation ensures timely project delivery and strict adherence to international regulatory standards. Lambda’s exemplary regulatory track record includes over 60 successful inspections and audits by esteemed authorities, including the USFDA, EMEA, MHRA, EU member states, and other global regulatory bodies, in the past five years.
Lambda’s commitment to excellence has garnered significant recognition, including the ‘Best Indian CRO’ award from Frost & Sullivan (USA) and the ‘Great Indian Workplace’ title from UBS Transformance. Recent accolades include the ‘Regulatory Excellence’ Award at the CPhI Pharma Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023.
