FDA EIR - Hetero Labs Limited (Unit V) - August 12, 2022

An unannounced, for-cause follow-up inspection by the Food and Drug Administration (FDA) was conducted at Hetero Labs Limited (Unit V) from August 4 to August 12, 2022. This inspection, carried out under drug manufacturing and field alert report compliance programs, assessed the firm's adherence to regulatory standards, particularly following a previous Warning Letter issued in 2017 and a 2019 inspection that resulted in deficiencies.

During the 2022 inspection, the FDA identified six significant issues, leading to a new FDA-483. Key observations included inadequate adherence to quality control unit responsibilities, incomplete investigation records for drug complaints, failure to submit Field Alert Reports within the required three working days, insufficient employee training for manufacturing tasks, lack of established and followed procedures for equipment cleaning and maintenance, and inadequate controls over computer systems for master record changes.

The inspection concluded with an "Official Action Indicated" (OAI) classification, and a warning letter is being recommended. This recommendation stems from a systemic failure of the quality system to adequately perform its responsibilities, including observations related to inadequate equipment cleaning and control of cross-contamination, and failure to re-validate critical process parameters. The company's Vice President acknowledged the observations and committed to submitting a formal response within 15 business days.