Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-02.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Jul 2024 – 2 Aug 2024 | Human Drugs | 483 | View 483 → |
| 23 Aug 2023 – 26 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Jun 2023 – 27 Jun 2023 | Human Drugs | 483 | View 483 → |
| 31 Oct 2019 – 7 Nov 2019 | Human Drugs | 483 | View 483 → |
| 21 May 2018 – 29 May 2018 | Human Drugs | Clean | |
| 15 Feb 2018 – 23 Feb 2018 | Human Drugs | 483 | View 483 → |
| 10 Sep 2015 – 18 Sep 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Aug 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jeffrey P Raimondi, Roger F Zabinski
2 Aug 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jeffrey P Raimondi, Roger F Zabinski
2 Aug 2024
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Jeffrey P Raimondi, Roger F Zabinski
26 Aug 2023
21 CFR 820.70(g)
Equipment Installation, Placement, Specified Requirements
Cited by Dipesh K Shah
Investigators
FDA investigators tied to this site in the record.
Jeffrey P Raimondi1 insp.
Roger F Zabinski1 insp.
Dipesh K Shah1 insp.
Truong X Nguyen1 insp.
Peng Zhou1 insp.
Michael A Charles1 insp.
Matthew B Casale1 insp.
Eileen A Liu1 insp.
Farhana Khan1 insp.
Angela E Glenn1 insp.
Santos E Camara1 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 | 4x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.48(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.186 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gland Pharma Limited's 6 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