The WL highlighted that the company has initiated recalls/additional process controls and testing of all manufactured batches of certain API, post the mention by regulatory agencies. There has been failure to ensure that equipment surface in contact with the API does not alter it beyond the established specification. Though the company has engaged a consultant to evaluate operations, the WL highlighted that the firms management will be responsible for fully resolving all deficiencies to ensure CGMP compliance. The WL also indicated that the USFDA has cited similar CGMP observations at other sites Unit I and Unit IX. the USFDA would require comprehensive measures to ensure adequate quality oversight of operations/equipment that could affect the drug quality, including any revised qualification and evaluation procedures. The USFDA would also require an update on the CAPA plans already initiated by ARBP, in addition to a thorough review of all API batches made at ARBP sites, in terms of impurities above reported thresholds.