# FDA 483 - Lupin Limited - May 19, 2017

Source: https://www.keypedia.com/records/483/lupin-limited/30e9d710-779f-493f-8ea4-d04364d3ed53

> FDA 483 for Lupin Limited on May 19, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Lupin Limited
- Inspection Date: 2017-05-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Lupin Limited, a drug manufacturer in Indore, India, received a Form 483 with six observations during an FDA inspection. The firm demonstrated significant quality control issues, including a high rate of invalidated Out-of-Specification results attributed to human error and inadequate investigation records. Further concerns were raised regarding insufficient written procedures for process controls, deficient batch records, poorly qualified stability chambers, and a lack of procedures for equipment maintenance.

## Related Documents

- [483 - 2017-05-19](https://www.keypedia.com/records/483/lupin-limited/77cdb6c3-8757-4eda-8414-0486dd545093)
- [483 - 2019-01-25](https://www.keypedia.com/records/483/lupin-limited/70b65220-35c3-48b6-89b1-0be80e795312)
- [483 - 2023-03-29](https://www.keypedia.com/records/483/lupin-limited/cb2a61fc-450e-46a8-b38d-d73ceb8fec78)
- [483 - 2025-07-17](https://www.keypedia.com/records/483/lupin-limited/d00d48e1-5b54-4a56-ade6-d91c498b7c4a)
- [483 - 2023-03-29](https://www.keypedia.com/records/483/lupin-limited/f06831df-7020-4ea9-8e5d-b47ca946e828)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)
- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

Company: https://www.keypedia.com/companies/lupin-limited/8707ad63-3e60-4c11-9138-77be2a49865c

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