Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-24.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Oct 2025 – 24 Oct 2025 | Human Drugs | 483 | View 483 → |
| 20 Sep 2023 – 26 Sep 2023 | Human Drugs | Clean | |
| 8 Aug 2022 – 18 Aug 2022 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Aug 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Junho Pak, Jessica S Estriplet, Karen A Briggs
18 Aug 2022
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Junho Pak, Jessica S Estriplet, Karen A Briggs
18 Aug 2022
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Junho Pak, Jessica S Estriplet, Karen A Briggs
Investigators
FDA investigators tied to this site in the record.
Luxuly Abraham1 insp.
Annet R Rajan1 insp.
Junho Pak1 insp.
Jessica S Estriplet1 insp.
Karen A Briggs1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aarkish Pharmaceuticals NJ Inc's 2 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