Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-01.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Apr 2026 – 1 May 2026 | Human Drugs | 483 | On file |
| 24 Jul 2023 – 28 Jul 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Jun 2023 – 16 Jun 2023 | Human Drugs | 483 | View 483 → |
| 17 Jan 2023 – 27 Jan 2023 | Human Drugs | 483 | On file |
| 15 Jul 2019 – 17 Jul 2019 | Human Drugs | Clean | |
| 20 Aug 2018 – 24 Aug 2018 | Human Drugs | 483 | View 483 → |
| 13 Nov 2017 – 17 Nov 2017 | Human Drugs | Clean | |
| 12 Oct 2015 – 14 Oct 2015 | 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.
Patty P Kaewussdangkul1 insp.
Chad W Rice1 insp.
Dipesh K Shah1 insp.
Jazmine N Brown1 insp.
Santos E Camara1 insp.
Alan P Kurtzberg1 insp.
Lata C Mathew1 insp.
Roger F Zabinski1 insp.
Charanjeet Jassal1 insp.
Zhongren Wu1 insp.
Meisha R Sampson1 insp.
Meisha R Waters1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.125(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.186 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Apothecon Pharmaceuticals Private Limited's 5 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