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

Source: https://www.keypedia.com/records/483/lupin-limited-biotech-division/2f83ecb9-d4dc-4906-8888-837267f95c95

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

---

## 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, Maharashtra, India, was cited for significant deficiencies in its drug substance and drug product manufacturing operations. The inspection revealed inadequate written procedures for production and process controls, failures in preventing microbial contamination during aseptic processing, and insufficient visual inspection procedures for sterile liquid drug products. Overall, the firm demonstrated a lack of adherence to established SOPs and protocols, indicating a compromised state of quality assurance and facility control.

## Related Documents

- [483 - 2022-10-14](https://www.keypedia.com/records/483/lupin-limited-biotech-division/fba695c4-7c84-4c77-be5a-4e943aef6afb)
- [483 - 2022-10-14](https://www.keypedia.com/records/483/lupin-limited-biotech-division/1b18d11a-1dd5-459b-bcba-13c20a20aa52)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/lupin-limited-biotech-division/109857c7-16e4-42ca-9b61-1e767b235dbb)
- [483 - 2025-09-19](https://www.keypedia.com/records/483/lupin-limited-biotech-division/25ae6777-20e4-4f88-9cb0-cd2ad37ec3be)

## Related Officers

- [Bingchen Du](https://www.keypedia.com/people/bingchen-du/2df8f706-844c-46b1-8461-51f0b9f0585b)
- [other](https://www.keypedia.com/people/hamet-m-toure/9f3726f3-b118-4247-9793-738557aa1ee8)
- [Hamet Touré](https://www.keypedia.com/people/hamet-toure/611bd66b-e975-4be5-9ac5-7a2ee17bfd91)

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