# FDA 483 - Teyro Labs Private Limited - March 03, 2023

Source: https://www.keypedia.com/records/483/teyro-labs-private-limited/1618a6e9-644c-4a5d-8403-f92b2998bf30

> FDA 483 for Teyro Labs Private Limited on March 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teyro Labs Private Limited
- Inspection Date: 2023-03-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Teyro Labs Private Limited in Kanchivakkam, Tamil Nadu, India, was inspected from February 20 to March 3, 2023, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in aseptic processing procedures, process validation, quality control unit responsibilities, and equipment cleaning and maintenance, indicating a lack of adherence to cGMP requirements for drug manufacturing.

## Related Documents

- [483 - 2015-03-27](https://www.keypedia.com/records/483/teyro-labs-private-limited/dcefd679-ba3a-4b88-ae97-5b9e7b2bda8f)
- [483 - 2025-11-12](https://www.keypedia.com/records/483/teyro-labs-private-limited/bcfa7d8d-c986-4393-85f1-2b576ee49dda)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/teyro-labs-private-limited/8744f9fc-f440-4610-ac34-05b15c46173b

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