# FDA 483 - Immacule Lifesciences Private Limited - March 14, 2023

Source: https://www.keypedia.com/records/483/immacule-lifesciences-private-limited/be36de17-8c23-4444-b7d9-6adc8c0ea6a1

> FDA 483 for Immacule Lifesciences Private Limited on March 14, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Immacule Lifesciences Private Limited
- Inspection Date: 2023-03-14
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Immacule Lifesciences Private Limited, a sterile drug manufacturer in Thanthuwal, India, revealed significant deficiencies in aseptic processing and quality control. Observations included a lack of established and followed procedures to prevent microbiological contamination during sterile drug production, and an inadequate quality control unit failing to properly approve and reject procedures and specifications, as evidenced by issues with change control and inaccurate particle counter listings.

## 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 - 2025-09-18](https://www.keypedia.com/records/483/immacule-lifesciences-private-limited/8059d79c-f857-491f-a578-f57387964f23)
- [483 - 2025-09-18](https://www.keypedia.com/records/483/immacule-lifesciences-private-limited/f1ce3e15-65c6-4d97-9b85-1cce1f2ef00c)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

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

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