Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-17.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Jun 2025 – 17 Jun 2025 | Human Drugs | 483 | View 483 → |
| 4 Apr 2022 – 19 May 2022 | Human Drugs | 483 | View 483 → |
| 4 May 2020 – 7 May 2020 | Human Drugs | Clean | |
| 22 Jul 2019 – 26 Jul 2019 | Human Drugs | 483 | View 483 → |
| 14 May 2018 – 18 May 2018 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Procedures for sterile drug products
Cited by Saundrea A Munroe, Damaris Y Hernandez, Luis P Torres, Homero W Aguilar
Authority lacking to review records, investigate errors
Cited by Saundrea A Munroe, Damaris Y Hernandez, Luis P Torres, Homero W Aguilar
Training , Education , Experience overall
Cited by Saundrea A Munroe, Damaris Y Hernandez, Luis P Torres, Homero W Aguilar
Written procedures not established/followed
Cited by Saundrea A Munroe, Damaris Y Hernandez, Luis P Torres, Homero W Aguilar
Reports of Analysis (Components)
Cited by Saundrea A Munroe, Damaris Y Hernandez, Luis P Torres, Homero W Aguilar
Investigators
FDA investigators tied to this site in the record.
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 | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Glenmark Pharmaceuticals Inc USA's 4 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