FDA EIR - Strides Pharma, Inc. - February 08, 2022

An FDA inspection of Strides Pharmaceutical Inc. in Chestnut Ridge, NY, took place from January 27 to February 8, 2022. This was Strides' first FDA inspection since acquiring the facility and drug product applications from Par Pharmaceuticals Inc. in August 2021. The inspection focused on Current Good Manufacturing Practice (cGMP) compliance for various drug product forms, aligning with Compliance Program Guidance Manuals 7352.832 and 7356.002 for drug manufacturing.The inspection identified two main deficiencies, resulting in a Form FDA 483, Inspectional Observations. Firstly, the company did not consistently follow and document its established laboratory control mechanisms. Secondly, packaging and labeling facilities were not adequately inspected after use to ensure that all unsuitable materials were removed before subsequent operations.Strides' management acknowledged the observations and committed to providing a formal response to the FDA-483 within 15 business days. The inspection was classified as Voluntary Action Indicated (VAI), signifying that the company is expected to implement corrective actions voluntarily.