# FDA 483 - Steril-Gene Life Sciences Private Ltd - December 10, 2019

Source: https://www.keypedia.com/records/483/steril-gene-life-sciences-private-ltd/8a3f06bd-b9dc-48ec-840b-bbda2031a3db

> FDA 483 for Steril-Gene Life Sciences Private Ltd on December 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steril-Gene Life Sciences Private Ltd
- Inspection Date: 2019-12-10
- Product Type: drugs
- Office Name: Foreign - CVM (Bioresearch Monitoring)
- Summary: Steril-Gene Life Sciences Pvt Ltd, a contract sterile drug product manufacturer in Puducherry, India, was cited with two observations during an FDA inspection. The observations concern failures to follow written production procedures, specifically regarding visual inspection of vials, and deficiencies in cleaning and maintenance procedures for equipment, including inadequate cleaning validation sampling plans for manufacturing tanks.

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## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)

Company: https://www.keypedia.com/companies/steril-gene-life-sciences-private-ltd/0885ef5e-2fd7-42c0-927d-7cf3c2410eec

Office: https://www.keypedia.com/offices/foreign-cvm-bioresearch-monitoring/53e70745-81df-4996-bd75-60b60e3be0c4