FDA 483 - Colgate-Palmolive India Ltd. - May 03, 2019

An FDA inspection of Colgate-Palmolive India Ltd., a contract testing lab in Mumbai, revealed significant deficiencies in laboratory record-keeping and electronic data management. The firm failed to maintain complete data records and lacked adequate audit trail features for its electronic logbook registry. Additionally, the quality control unit's responsibilities and procedures were not adequately documented or followed, leading to issues with logbook issuance and reconciliation.