FDA 483 - Harman Finochem Limited - March 22, 2024

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from March 18-22, 2024, at Harman Finochem Ltd., an Active Pharmaceutical Ingredient (API) manufacturer located in Aurangabad, India, significant concerns were identified regarding laboratory controls. The inspection resulted in the issuance of an FDA Form 483, detailing observations of non-compliance.The primary observation highlighted that the company's laboratory controls lacked scientifically sound and appropriate specifications, sampling plans, and test procedures to ensure raw materials meet established quality and purity standards. Specifically, the method used for microbiological analysis of water, designated as (b)(4) water, had not been validated to demonstrate growth recovery for microbiological species was equal to or more effective than the established USP method. This particular water is crucial as it is utilized in the production of non-sterile APIs, including (b)(4) USP and (b)(4) USP, intended for the US market.Furthermore, the inspection noted a lack of scientific justification for the quantity of (b)(4) employed during the water testing procedure. These observations indicate deficiencies in the firm's quality control processes for critical manufacturing inputs. Harman Finochem Ltd. is expected to address these findings by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory expectations for API manufacturing.