# FDA 483 - Alkem Laboratories Limited - July 03, 2026

Source: https://www.keypedia.com/records/483/alkem-laboratories-limited/a2328e30-243b-4402-b006-29b34c057146

> FDA 483 for Alkem Laboratories Limited on July 03, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Alkem Laboratories Limited
- Inspection Date: 2026-07-03
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Rubicon Research Limited, a drug manufacturer in Pithampur, India, received a Form 483 citing significant deficiencies during an FDA inspection. The observations primarily concerned failures in equipment qualification for manufacturing, labeling, and packaging operations. Additionally, the firm lacked established and followed written procedures for equipment cleaning and maintenance, including proper documentation of cleaning activities.

## Related Documents

- [483 - 2022-07-07](https://www.keypedia.com/records/483/alkem-laboratories-limited/986bb138-e379-4947-954f-46257e20f36b)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.keypedia.com/companies/alkem-laboratories-limited/278691dd-5d9a-4c1d-ba5e-72166fce32d1

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3