Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-22.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Nov 2024 – 22 Nov 2024 | Human Drugs | Clean | |
| 21 Feb 2023 – 3 Mar 2023 | Human Drugs | 483 | On file |
| 7 Feb 2022 – 22 Feb 2022 | Human Drugs | 483 | View 483 → |
| 17 Dec 2018 – 21 Dec 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Feb 2022
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by David A Oluwo, Daniel J Min
22 Feb 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by David A Oluwo, Daniel J Min
22 Feb 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by David A Oluwo, Daniel J Min
Investigators
FDA investigators tied to this site in the record.
Daniel J Min2 insp.
Gabrielle J Swain1 insp.
Amit Kokate1 insp.
Janet A Rajan1 insp.
David A Oluwo1 insp.
Junho Pak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind I 3 PHARMACEUTICALS, LLC's 3 Form 483s
Source PDFs, verbatim observations, 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