FDA EIR - Strides Alathur Private Limited - April 05, 2024

An FDA inspection of Strides Alathur Private Limited, a human and animal drug manufacturer located in Chengalpattu, India, was conducted from April 1 to April 5, 2024. This comprehensive inspection focused on adherence to current Good Manufacturing Practices (cGMP) for non-sterile tablets and capsules, covering quality, production, laboratory, and facilities and equipment systems, with partial coverage of materials and packaging/labeling. The inspection was performed under Compliance Programs 7356.002 and 7371.001, for drug and animal drug manufacturing, respectively. During the close-out meeting on April 5, 2024, a Form FD 483, Inspectional Observations, was issued to Mr. Umesh P. Kale, Chief Quality Officer, detailing two primary deficiencies. These included insufficient investigations into unexplained discrepancies in control records, such as deviations and market complaints. Additionally, the Document Control System was found to be inadequate for timely and accurate replication of electronic records outside the system. Sixteen other discussion points were also raised. Strides Alathur Private Limited management acknowledged the observations and committed to providing a response within fifteen business days. The FDA informed the company that these conditions, upon further agency review, could be deemed violations of the Federal Food, Drug, and Cosmetic Act, potentially leading to legal sanctions, including the refusal or detention of their products upon entry into the United States. The inspection concluded with firm management demonstrating cooperation.