Immacule Lifesciences Private Limited
FDA inspection history across 2 sites, 2022 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Nalagarh, India.
- 2025One Form 483, at Solan, India.
- 2025The longest 483 on file: 8 observations over 16 pages at Solan, India.
Cited most
Across all Immacule Lifesciences Private Limited observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
The complete Immacule Lifesciences Private Limited file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Solan, India
One Form 483 · 2025 · 8 observations
Latest: Form 483, Sep 18, 2025 →Nalagarh, India
One Form 483 · 2022 · 8 observations
Latest: Form 483, Jun 20, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-18 | 483 Form 483 | Solan, India | 8 | $99 |
| 2022-06-20 | 483 Form 483 | Nalagarh, India | 8 | $99 |
Investigators on these documents
Angelica M. Hernandez (1)Cynthia Jim (1)Damaris Y. Hernandez (1)Jose E. Melendez (1)Wayne D. McGrath (1)
FEI number 3014210753 · most recent document Sep 18, 2025
About Immacule Lifesciences Private Limited
How many FDA Form 483s has Immacule Lifesciences Private Limited received?
FDA Intel has 2 Form 483s on file for Immacule Lifesciences Private Limited; the most recent is dated Sep 18, 2025.
When was Immacule Lifesciences Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Immacule Lifesciences Private Limited is a Form 483 dated Sep 18, 2025, for the site in Solan, India.
What did FDA cite at Immacule Lifesciences Private Limited?
The regulations cited most in the observations on file for Immacule Lifesciences Private Limited are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.42 (Design and construction features), 2 times.