FDA EIR - Shree Mahadev Intermediate - February 07, 2019

An FDA pre-approval inspection of Shree Mahadev Intermediate, located in Ankleshwar, India, was conducted from February 5-7, 2019. This initial inspection focused on the firm's manufacturing operations for an intermediate product, under the regulatory framework of CPGM 7346.832, Pre-Approval Inspections, and the Food, Drug, and Cosmetic (FD&C) Act. The inspection covered quality, facilities and equipment, materials, production, and laboratory systems.The inspection resulted in an Official Action Indicated (OAI) classification, with a recommendation to "Withhold" approval, due to significant deficiencies. A ten-item Form FDA 483, Inspectional Observations, was issued, detailing multiple violations of good manufacturing practices (cGMP). Key issues included inadequate written procedures and adherence for the quality control unit, insufficient recordkeeping for production and materials, and a lack of employee training in job functions and cGMP. The facility also exhibited poorly maintained equipment, unsuitable building construction for cleanliness, and a failure to establish systems for managing rejected materials or performing raw material testing. Other concerns involved the absence of a statistically significant sampling plan, inadequate control over batch production records, and unvalidated analytical methods. Verbal observations further highlighted a deficient change control program and neglected supplier audits.The firm's Managing Director promised a written response to the FDA 483 within 15 business days and committed to making necessary corrections to address the noted issues and ensure compliance with regulatory requirements.