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

Source: https://www.globalkeysolutions.net/records/483/colgate-palmolive-india-ltd/b0556e5d-63fb-4cc7-aee1-f9d05834d06c

> FDA 483 for Colgate-Palmolive India Ltd. on May 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Colgate-Palmolive India Ltd.
- Inspection Date: 2019-05-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

Company: https://www.globalkeysolutions.net/companies/colgate-palmolive-india-ltd/dfeb976a-a43b-474b-8b13-58ce9e5a6204

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1