Lambda Therapeutic Research has successfully completed an unannounced US FDA inspection with zero Form 483 observations. The inspection was conducted from 27 April to 01 May 2026.
The scope of the inspection included the bioanalytical evaluation of four studies, along with a detailed review of method validation records.
During the inspection, key operational areas were reviewed, including laboratory practices, sample management processes, data workflow, and documentation systems. Positive feedback was received on the cleanliness and organization of laboratory areas, as well as the clarity and accuracy of documentation and data handling practices.
This outcome reflects the strength of Lambda’s quality systems, structured processes, and consistent focus on compliance and data integrity across bioanalytical operations.
Inspection Details:
- Facility Inspected: Lambda Therapeutic Research, Ahmedabad
- Scope: Bioanalytical (4 studies)
- Outcome: No Form 483 Observations
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.
