Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-18.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Sep 2025 – 18 Sep 2025 | Human Drugs | 483 | On file |
| 6 Mar 2023 – 14 Mar 2023 | Human Drugs | 483 | On file |
| 9 Jun 2022 – 20 Jun 2022 | Human Drugs | 483 | On file |
| 1 May 2019 – 10 May 2019 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez1 insp.
Damaris Y Hernandez1 insp.
Angelica M Hernandez1 insp.
Nicole E Knowlton1 insp.
Wayne D Mcgrath1 insp.
Cynthia Jim1 insp.
Dennis Cantellops Paite1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Immacule Lifesciences Private Limited's 3 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat