# FDA 483 - Reliance Life Sciences Private Limited - February 27, 2026

Source: https://www.keypedia.com/records/483/reliance-life-sciences-private-limited/47dfda7e-50c5-402d-8722-6d7100a1f1e7

> FDA 483 for Reliance Life Sciences Private Limited on February 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reliance Life Sciences Private Limited
- Inspection Date: 2026-02-27
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Reliance Life Sciences Private Limited, located in Navi Mumbai, India, underwent an FDA inspection from February 19 to February 27, 2026. The inspection resulted in several significant observations regarding the facility"s adherence to Current Good Manufacturing Practice (cGMP) standards, primarily focusing on data integrity failures and inadequate sterile processing controls. Investigators discovered that laboratory personnel documented environmental monitoring samples that were never actually collected, even fabricating "Nil" microbial results in official logbooks. Furthermore, the firm’s microbial limit testing was fundamentally flawed; investigators identified multiple stability failures—including one batch already distributed in the U.S. market—that the company had incorrectly recorded as passing due to calculation errors and the omission of dilution factors. Aseptic manufacturing concerns were also prominent. Observations included operators blocking unidirectional airflow in critical zones, the use of non-sterile cleaning materials in high-grade areas, and a failure to investigate particle count alarms during production. Additionally, the firm’s smoke studies showed turbulent airflow, and aseptic simulations did not reflect worst-case manufacturing conditions. Finally, the firm’s quality system was found to be insufficient, as critical equipment malfunctions were handled through maintenance orders rather than formal deviation investigations, preventing root-cause analysis and impact assessments. This Form 483 represents preliminary findings. Reliance Life Sciences is required to submit a comprehensive written response to the FDA detailing its corrective and preventive actions to address these systemic deficiencies in data reliability and sterile manufacturing oversight.

## Related Documents

- [483 - 2026-02-27](https://www.keypedia.com/records/483/reliance-life-sciences-private-limited/43ee35e0-0c20-4849-9f73-a6f046f78841)

## Related Officers

- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)
- [Ashar P. Parikh](https://www.keypedia.com/people/ashar-p-parikh/f5430c51-31c7-44bb-90f7-1ec8ae581343)

Company: https://www.keypedia.com/companies/reliance-life-sciences-private-limited/14b16d70-e482-4647-a231-4eb4a1aab98f

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c