# FDA 483 - Lupin Limited - February 08, 2019

Source: https://www.keypedia.com/records/483/lupin-limited/da3d7c14-a7e7-4b26-92d8-d5fff43653d3

> FDA 483 for Lupin Limited on February 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2019-02-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Lupin Limited in Verna, India, was cited with a Form 483 following an FDA inspection from January 28 to February 8, 2019. The inspection revealed significant deficiencies in the firm's quality control, including a failure to thoroughly investigate out-of-specification results and product defects before releasing drug products to the U.S. market. Additionally, the firm lacked adequate written procedures for critical production and process controls, leading to unvalidated manufacturing steps and unrecorded deviations.

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## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.keypedia.com/companies/lupin-limited/218ee27f-639e-4fc4-995c-345bc58c3548

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