# FDA 483 - Lupin Limited - September 20, 2019

Source: https://www.keypedia.com/records/483/lupin-limited/d6cb5c15-08e8-4f40-8520-87f69e1693f5

> FDA 483 for Lupin Limited on September 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2019-09-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Lupin Limited in Tarapur, India, an API manufacturer, was cited with three observations during an FDA inspection. The observations primarily concern inadequate investigations into discrepancies, deficiencies in batch production and control records, and improper handling and storage of cleaned utensils, indicating significant issues with quality control and contamination prevention.

## Related Documents

- [483 - 2019-09-20](https://www.keypedia.com/records/483/lupin-limited/6012146e-52c1-43f3-8900-ce7f0ca2cb6e)
- [483 - 2022-04-04](https://www.keypedia.com/records/483/lupin-limited/5acd6e49-aec0-480b-9c98-b660af087f3c)

## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.keypedia.com/companies/lupin-limited/c5d5c5f9-442a-476b-86e3-261a12e58f9b

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