# FDA 483 - Alnylam Pharmaceuticals Inc. - February 25, 2025

Source: https://www.keypedia.com/records/483/alnylam-pharmaceuticals-inc/c1f4128d-8509-47ae-b160-11cecceecf5d

> FDA 483 for Alnylam Pharmaceuticals Inc. on February 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alnylam Pharmaceuticals Inc.
- Inspection Date: 2025-02-25
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Alnylam Pharmaceuticals Inc. in Cambridge, MA, revealed significant deficiencies in manufacturing practices. Observations included inadequate testing of components for impurities, distribution of drug product lots prior to complete quality unit approval, and failure to maintain production and control records for the required duration. These issues indicate potential risks to drug product quality and regulatory compliance.

## Related Officers

- [Ogechi C. Nna](https://www.keypedia.com/people/ogechi-c-nna/59452184-8197-4ba6-bf1d-78a7e003ef2c)
- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)

Company: https://www.keypedia.com/companies/alnylam-pharmaceuticals-inc/285be436-d642-438b-ac4c-530088c678b8

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144