# FDA 483 - Centurion Laboratories Private Limited - October 26, 2018

Source: https://www.keypedia.com/records/483/centurion-laboratories-private-limited/d0c9dd23-9f83-4b01-8fc6-cade14f02adc

> FDA 483 for Centurion Laboratories Private Limited on October 26, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centurion Laboratories Private Limited
- Inspection Date: 2018-10-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Centurion Laboratories Private Limited in Manjusar, Gujarat, revealed critical deficiencies in personnel training, equipment maintenance, and data integrity. The firm lacked adequate written procedures for cleaning and process controls, and numerous pieces of manufacturing equipment were found visibly dirty. Significant issues were also noted with computerized systems, including unauthorized access and the ability to delete raw data, alongside incomplete laboratory records and unperformed compendial testing for US-marketed products.

## Related Officers

- [Yvins Dezan](https://www.keypedia.com/people/yvins-dezan/e9fd12e6-c090-4eb6-bc78-8b80e8a90946)

Company: https://www.keypedia.com/companies/centurion-laboratories-private-limited/1ddd1e57-4d77-4775-a6e2-8eea6e76209c

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