Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-29.
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 |
|---|---|---|---|
| 25 Mar 2024 – 29 Mar 2024 | Human Drugs | 483 | View 483 → |
| 1 Jul 2019 – 5 Jul 2019 | Human Drugs | Clean | |
| 15 Jan 2018 – 19 Jan 2018 | Human Drugs | 483 | On file |
| 15 May 2017 – 19 May 2017 | Human Drugs | 483 | View 483 → |
| 5 Oct 2015 – 9 Oct 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
19 May 2017
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Alan P Kurtzberg
19 May 2017
21 CFR 211.188
Prepared for each batch, include complete information
Cited by Alan P Kurtzberg
Investigators
FDA investigators tied to this site in the record.
Ankur C Patel1 insp.
Jose M Cayuela1 insp.
Atul Agrawal1 insp.
Satheesh Thomas1 insp.
Alan P Kurtzberg1 insp.
Erika V Butler1 insp.
Pratik S Upadhyay1 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 | 6x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.188(b)(12) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind UMEDICA LABORATORIES PRIVATE LIMITED's 4 Form 483s
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