Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-25.
At a glance
Inspections
11
Form 483s
7
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jul 2024 – 25 Jul 2024 | Human Drugs | 483 | View 483 → |
| 3 Jul 2023 – 14 Jul 2023 | Human Drugs | 483 | View 483 → |
| 22 Aug 2022 – 25 Aug 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 May 2019 – 16 May 2019 | Human Drugs | 483 | View 483 → |
| 23 Jan 2017 – 3 Feb 2017 | Human Drugs | 483 | View 483 → |
| 18 Jul 2016 – 26 Jul 2016 | Human Drugs | Clean | |
| 9 Mar 2015 – 17 Mar 2015 | Human Drugs | 483 | View 483 → |
| 7 Sep 2012 | Not recorded | 483 | View 483 → |
| 7 Jan 2011 | Not recorded | Clean | |
| 18 Apr 2006 | Not recorded | Clean | |
| 16 Sep 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2024
21 CFR 211.180(b)
Record maintenance 1 year (except exempt OTC)
Cited by Jeffrey P Raimondi, Roger F Zabinski
25 Jul 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jeffrey P Raimondi, Roger F Zabinski
14 Jul 2023
21 CFR 211.194(a)
Complete test data included in records
Cited by Alan P Kurtzberg, Youkeun Kim
Investigators
FDA investigators tied to this site in the record.
Jose A Cruz Gonzalez2 insp.
Jeffrey P Raimondi1 insp.
Roger F Zabinski1 insp.
Alan P Kurtzberg1 insp.
Youkeun Kim1 insp.
Joshua J Silvestri1 insp.
Michael A Charles1 insp.
Ademola O Daramola1 insp.
Katherine D Adams1 insp.
Carla J Lundi1 insp.
Ivis L Negron Torres1 insp.
Kham Phommachanh1 insp.
Parul M Patel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | 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 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gland Pharma Limited's 7 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