# FDA 483 - Colgate-Palmolive Company - July 15, 2021

Source: https://www.globalkeysolutions.net/records/483/colgate-palmolive-company/64a3d90f-3111-4b14-a848-203a0548eaf8

> FDA 483 for Colgate-Palmolive Company on July 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Colgate-Palmolive Company
- Inspection Date: 2021-07-15
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Colgate-Palmolive Company in Morristown, TN, revealed significant deficiencies in their quality system. Observations included inadequate documentation for Medical Device Reporting (MDR) event files, insufficient process validation procedures for equipment maintenance, and failures in complaint evaluation and investigation. Additionally, the firm lacked adequately established procedures for routine equipment calibration.

## Related Officers

- [Benjamin E. Bowen](https://www.globalkeysolutions.net/people/benjamin-e-bowen/7fdc5755-0d5d-45c9-93a0-3cb928156c1d)
- [Gamal A. Norton](https://www.globalkeysolutions.net/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.globalkeysolutions.net/companies/colgate-palmolive-company/7db665f6-094f-4de5-bf3b-c2528e2a223b

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea