Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-25.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Feb 2025 – 25 Feb 2025 | Human Drugs | 483 | View 483 → |
| 20 May 2024 – 24 May 2024 | Human Drugs | Clean | |
| 23 Jan 2023 – 27 Jan 2023 | Human Drugs | Clean | |
| 16 Apr 2018 – 20 Apr 2018 | Human Drugs | 483 | On file |
| 26 Oct 2015 – 29 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.
Ashar P Parikh1 insp.
Frederick Razzaghi1 insp.
Dennis Cantellops Paite1 insp.
Tonia F Bernard1 insp.
Deyaa Shaheen1 insp.
Qin Xu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gland Pharma Limited'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