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

Source: https://www.keypedia.com/records/483/immacule-lifesciences-private-limited/8059d79c-f857-491f-a578-f57387964f23

> 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 Inspections and Investigations
- Summary: An FDA inspection of Immacule Lifesciences Private Limited in Solan, India, conducted from September 8 to September 18, 2025, identified critical deficiencies in the company"s adherence to Current Good Manufacturing Practices (cGMP) for sterile drug products. The observations primarily concerned the Quality Control Unit (QCU) and procedures for preventing microbiological contamination. The QCU failed to ensure that production and laboratory operations consistently met cGMP requirements, lacking adequate assessments of practices impacting sterile product quality. Environmental trend reports for controlled areas were deemed insufficient, providing an incomplete picture of microbial recoveries and necessary corrective actions. 

Significant issues in contamination control were also noted, including improper sanitization techniques where marker ink smeared during cleaning, potentially compromising sterile surfaces. Operators did not adequately sanitize all required surfaces during pre-environmental monitoring. Furthermore, airflow patterns in the sterile filling room were not comprehensively assessed for personnel impact, and historical smoke studies did not accurately reflect aseptic manufacturing conditions. Specific instances included unsanitized contact with sterile materials, operator garments touching non-sanitized equipment, and observed turbulence during transfers. Immacule Lifesciences is required to implement comprehensive corrective actions to address these observations and ensure product safety and quality.

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## 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-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8