FDA EIR - Laurus Labs Limited - June 14, 2019

A surveillance inspection by the Food and Drug Administration (FDA) was conducted at Laurus Labs Limited in Visakhapatnam, India, from June 10 to June 14, 2019. This inspection, performed under the regulatory framework of CPGM 7356.002F for Active Pharmaceutical Ingredients, aimed to assess the company's adherence to Good Manufacturing Practices (GMP). Key violations identified during this inspection, detailed in a Form FDA 483, included a failure to adequately document preventative and corrective actions and insufficient record-keeping for Active Pharmaceutical Ingredient (API) labeling. Additional verbal observations covered issues such as a lack of clarity in batch records regarding ingredient quantities, inadequate documentation of process validation and equipment qualification, and an unvalidated laboratory instrument improperly labeled. The inspection resulted in a "Voluntary Action Indicated" (VAI) classification. Laurus Labs Limited was informed of its responsibility to ensure full compliance and committed to providing a written response to the FDA within 15 business days outlining their corrective actions. Future regulatory actions, such as warning letters, could follow if appropriate corrections are not implemented, with verification planned during the next inspection.