Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-27.
At a glance
Inspections
7
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Nov 2025 – 27 Nov 2025 | Human Drugs | 483 | On file |
| 27 Mar 2018 – 3 Apr 2018 | Human Drugs | WL | View 483 → |
| 27 Jun 2016 – 1 Jul 2016 | Human Drugs | 483 | On file |
| 27 Jan 2015 – 4 Feb 2015 | Human Drugs | 483 | View 483 → |
| 2 Dec 2013 – 10 Dec 2013 | Human Drugs | 483 | On file |
| 10 Oct 2012 | Not recorded | WL | View 483 → |
| 30 Mar 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Apr 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jose E Melendez, Ademola O Daramola
3 Apr 2018
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Jose E Melendez, Ademola O Daramola
3 Apr 2018
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Jose E Melendez, Ademola O Daramola
3 Apr 2018
21 CFR 211.165(a)
Testing and release for distribution
Cited by Jose E Melendez, Ademola O Daramola
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez2 insp.
Peter E Baker2 insp.
Angelica M Hernandez1 insp.
Alan A Rivera1 insp.
Ademola O Daramola1 insp.
Thomas J Arista1 insp.
Daniel J Roberts1 insp.
Sandra A Hughes1 insp.
Andrew J Idzior1 insp.
Parul M Patel1 insp.
Robert M Barbosa1 insp.
Larry K Austin1 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 | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.150 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | 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 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.48(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gland Chemicals Private 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