# FDA 483 - Teena Bio Labs Private Ltd - February 09, 2018

Source: https://www.keypedia.com/records/483/teena-bio-labs-private-ltd/1cd868e8-1f27-4300-be87-9f8cbff769e6

> FDA 483 for Teena Bio Labs Private Ltd on February 09, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teena Bio Labs Private Ltd
- Inspection Date: 2018-02-09
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Teena Biolabs Pvt Ltd, a control testing laboratory in Hyderabad, India, was cited for significant deficiencies in laboratory controls, including scientifically unsound test procedures and failure to follow established specifications. The inspection revealed issues with microbiological enumeration testing, particle size distribution methods, and instrument calibration, indicating a lack of assurance in drug product quality and purity. These findings suggest a moderate level of severity regarding quality system compliance.

## Related Documents

- [483 - 2017-03-15](https://www.keypedia.com/records/483/teena-bio-labs-private-ltd/f8effe26-7c92-4f1a-87c9-90390d9f21fe)

## Related Officers

- [Laurimer Kuilan-Torres](https://www.keypedia.com/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)

Company: https://www.keypedia.com/companies/teena-bio-labs-private-ltd/16beb558-8d6a-4125-bab3-520152a6e785

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321