# FDA 483 - Lupin Limited - Unknown Date

Source: https://www.keypedia.com/records/483/lupin-limited/0486e3a3-7887-41ff-9908-811e2a997f4e

> FDA 483 for Lupin Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Lupin Limited in Nagpur, India, received a Form FDA 483 with five observations following an inspection on October 20, 2022. The inspection revealed significant deficiencies in aseptic processing areas, including facility surfaces, microbiological contamination prevention procedures, inadequate validation of aseptic processes, and environmental monitoring systems. Additionally, the firm failed to thoroughly review unexplained discrepancies and out-of-specification events related to API shipment and sterility testing.

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## Related Officers

- [Cynthia Jim](https://www.keypedia.com/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)

Company: https://www.keypedia.com/companies/lupin-limited/b6e6db97-9d2a-4714-887a-0d966c3815c0

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