# FDA 483 - Lupin Limited (Biotech Division) - September 19, 2025

Source: https://www.keypedia.com/records/483/lupin-limited-biotech-division/25ae6777-20e4-4f88-9cb0-cd2ad37ec3be

> FDA 483 for Lupin Limited (Biotech Division) on September 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited (Biotech Division)
- Inspection Date: 2025-09-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Lupin Limited (Biotech Division) in Pune, India, was cited for significant deficiencies in its manufacturing processes for drug substances and drug products. Observations included a lack of adequate written procedures for production and process controls, failures in preventing microbial contamination of sterile products, and inadequate visual inspection procedures for sterile liquid drug products. The inspection revealed systemic issues across various SOPs, decontamination, sampling, and facility maintenance, indicating a broad lack of control over critical manufacturing operations.

## Related Documents

- [483 - 2022-10-14](https://www.keypedia.com/records/483/lupin-limited-biotech-division/1b18d11a-1dd5-459b-bcba-13c20a20aa52)
- [483 - 2022-10-14](https://www.keypedia.com/records/483/lupin-limited-biotech-division/fba695c4-7c84-4c77-be5a-4e943aef6afb)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/lupin-limited-biotech-division/109857c7-16e4-42ca-9b61-1e767b235dbb)

## Related Officers

- [Bingchen Du](https://www.keypedia.com/people/bingchen-du/2df8f706-844c-46b1-8461-51f0b9f0585b)
- [Hamet Touré, PharmD MPH, Regulatory Officer](https://www.keypedia.com/people/hamet-toure-pharmd-mph-regulatory-officer/90e0a7c5-7fff-4dfe-a893-7d7cad038a15)
- [other](https://www.keypedia.com/people/hamet-m-toure/9f3726f3-b118-4247-9793-738557aa1ee8)
- [Bingchen (Ben) Du, Ph.D., Pharmaceutical Scientist](https://www.keypedia.com/people/bingchen-ben-du-phd-pharmaceutical-scientist/faaa76a7-9cf8-4558-9249-009d2b26bc1e)

Company: https://www.keypedia.com/companies/lupin-limited-biotech-division/71a104da-9365-4836-afc4-9c80c8a9c4f0

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8