Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-08.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Nov 2022 – 8 Dec 2022 | Human Drugs | 483 | View 483 → |
| 6 Feb 2020 – 14 Feb 2020 | Human Drugs | 483 | View 483 → |
| 16 Feb 2018 – 21 Feb 2018 | Human Drugs | 483 | On file |
| 20 Feb 2017 – 24 Feb 2017 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Dec 2022
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Ucheabuchi C Chudi-Nwankwor, Sandra A Boyd
8 Dec 2022
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Ucheabuchi C Chudi-Nwankwor, Sandra A Boyd
8 Dec 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Ucheabuchi C Chudi-Nwankwor, Sandra A Boyd
8 Dec 2022
21 CFR 211.165(a)
Testing and release for distribution
Cited by Ucheabuchi C Chudi-Nwankwor, Sandra A Boyd
8 Dec 2022
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Ucheabuchi C Chudi-Nwankwor, Sandra A Boyd
Investigators
FDA investigators tied to this site in the record.
Ucheabuchi C Chudi-Nwankwor1 insp.
Sandra A Boyd1 insp.
Felix Maldonado1 insp.
Christopher S Keating1 insp.
Katherine D Adams1 insp.
Ivy E Sweeney1 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 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(11) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(8) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Galentic Pharma (India) Private Limited's 4 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