Immacule Lifesciences Private Limited
Form 483 issued September 18, 2025 · Solan, India
- Inspection
- Sep 8 – Sep 18, 2025
- Investigators
- Angelica M. Hernandez· Damaris Y. Hernandez· Jose E. Melendez
- Observations
- 8
- Pages
- 16
- FEI number
- 3014210753
In short: On September 18, 2025, FDA issued a Form 483 with 8 observations to Immacule Lifesciences Private Limited in Solan, India (FEI 3014210753) after an inspection that ran Sep 8 – Sep 18, 2025. The investigators were Angelica M. Hernandez, Damaris Y. Hernandez and Jose E. Melendez. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Angelica M. Hernandez
15 documents · 2022–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmImmacule Lifesciences Private Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Immacule Lifesciences Private Limited?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Immacule Lifesciences Private Limited?
Angelica M. Hernandez, Damaris Y. Hernandez and Jose E. Melendez are named on this Form 483, for the inspection of Sep 8 – Sep 18, 2025. Each investigator has a profile showing what they cite most.
When was Immacule Lifesciences Private Limited inspected by FDA?
The inspection ran Sep 8 – Sep 18, 2025, and the Form 483 is dated September 18, 2025.
How do I get the full Form 483 for Immacule Lifesciences Private Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.