Unexo Lifesciences, Private Limited

Warning LetterOpen

Mr. Saurabh Bansal Managing Director Unexo Lifesciences, Private Limited B16 Sector 4 Bawana Industrial Area New Delhi 110039 Delhi IndiaFEI 3013514280Issued Nov 6, 2024Center for Drug Evaluation and Research (CDER)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013514280.

Violations4

Issue DateNov 6, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Unexo Lifesciences, Private Limited
Location: Mr. Saurabh Bansal Managing Director Unexo Lifesciences, Private Limited B16 Sector 4 Bawana Industrial Area New Delhi 110039 Delhi India
FEI Number: 3013514280
Country: India
Issue Date: November 06, 2024
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Unexo Lifesciences, a drug manufacturer in New Delhi, India, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered its finished pharmaceutical products adulterated. The company's quality control and assurance units failed to exercise adequate oversight of drug product compliance, data reliability, and employee adherence to data integrity principles, with specific deficiencies including incomplete batch production and control records, some of which were found torn and stored improperly on the facility's rooftop. The FDA conducted an inspection from May 1-14, 2024, and issued this warning letter on November 6, 2024, following the company's June response to initial inspection findings.

Unexo Lifesciences, Private Limited FDA Warning Letter, November 6, 2024