# FDA 483 - Ocean Healthcare Pvt Ltd - June 14, 2024

Source: https://www.globalkeysolutions.net/records/483/ocean-healthcare-pvt-ltd/a01bdbbf-efc2-4e1b-a595-485d22374eae

> FDA 483 for Ocean Healthcare Pvt Ltd on June 14, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ocean Healthcare Pvt Ltd
- Inspection Date: 2024-06-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ocean Healthcare Pvt Ltd, a manufacturer in Chengalpattu District, India, was cited for three significant issues during an FDA inspection. Observations included inadequate written procedures for complaint investigations, failure to test components for conformity, and a lack of written procedures for the quality control unit, specifically regarding chromatographic data management. These findings indicate deficiencies in quality control and adherence to established manufacturing practices.

## Related Documents

- [483 - 2024-06-14](https://www.globalkeysolutions.net/records/483/ocean-healthcare-pvt-ltd/b786bec1-678a-4328-a897-655c969869e9)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ocean-healthcare-pvt-ltd/ab67b3d6-0320-4056-bf3d-4af22bbd125d

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