Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-21.
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 |
|---|---|---|---|
| 17 Feb 2025 – 21 Feb 2025 | Human Drugs | 483 | View 483 → |
| 23 Jan 2023 – 27 Jan 2023 | Human Drugs | WL | View 483 → |
| 21 Jan 2019 – 25 Jan 2019 | Human Drugs | 483 | View 483 → |
| 2 May 2016 – 6 May 2016 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Feb 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Tamil Arasu, Saleem A Akhtar
21 Feb 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tamil Arasu, Saleem A Akhtar
21 Feb 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Tamil Arasu, Saleem A Akhtar
Investigators
FDA investigators tied to this site in the record.
Tamil Arasu1 insp.
Saleem A Akhtar1 insp.
Arsen Karapetyan1 insp.
Teresa I Navas1 insp.
Santos E Camara1 insp.
Yumi J Hiramine1 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 | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | 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(a) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | 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 |
Full site report
Get the verbatim findings behind MEDGEL 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