# FDA 483 - Immacule Lifesciences Private Limited - September 18, 2025

Source: https://www.keypedia.com/records/483/immacule-lifesciences-private-limited/f1ce3e15-65c6-4d97-9b85-1cce1f2ef00c

> FDA 483 for Immacule Lifesciences Private Limited on September 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immacule Lifesciences Private Limited
- Inspection Date: 2025-09-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Immacule Lifesciences Private Limited in Solan, India, revealed critical deficiencies across its sterile drug product manufacturing operations. The firm's quality unit failed to ensure cGMP compliance and adequate environmental monitoring, while aseptic processing procedures were not properly established or followed, leading to contamination risks. Significant issues were also noted in equipment design, environmental monitoring systems, aseptic process validation, computerized system controls, laboratory investigations, and employee training, indicating a systemic lack of adherence to quality and sterility assurance for products destined for the USA market.

## Related Documents

- [483 - 2022-06-20](https://www.keypedia.com/records/483/immacule-lifesciences-private-limited/b81f665f-d73e-486c-a38a-e8b2b3c54129)
- [483 - 2023-03-14](https://www.keypedia.com/records/483/immacule-lifesciences-private-limited/3e72b02c-77b3-4490-85ba-90c1f12ba574)
- [483 - 2023-03-14](https://www.keypedia.com/records/483/immacule-lifesciences-private-limited/be36de17-8c23-4444-b7d9-6adc8c0ea6a1)
- [483 - 2025-09-18](https://www.keypedia.com/records/483/immacule-lifesciences-private-limited/8059d79c-f857-491f-a578-f57387964f23)

## Related Officers

- [Quality System Specialist](https://www.keypedia.com/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)
- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)
- [Angelica M. Hernandez](https://www.keypedia.com/people/angelica-m-hernandez/d66d920c-01b6-4770-a1b5-cac9a1790a0e)

Company: https://www.keypedia.com/companies/immacule-lifesciences-private-limited/7d74d2ff-8d6a-48d8-a552-c48c458bd5ba

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1