Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
8
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2025 – 21 Nov 2025 | Human Drugs | 483 | On file |
| 30 Oct 2023 – 9 Nov 2023 | Human Drugs | 483 | On file |
| 13 Feb 2020 – 25 Feb 2020 | Human Drugs | WL | On file |
| 29 Aug 2019 – 6 Sep 2019 | Human Drugs | 483 | View 483 → |
| 20 Nov 2017 – 30 Nov 2017 | Human Drugs | 483 | On file |
| 24 Jul 2017 – 28 Jul 2017 | Human Drugs | 483 | On file |
| 18 Jul 2016 – 26 Jul 2016 | Human Drugs | Clean | |
| 17 Aug 2015 – 26 Aug 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Sep 2019
21 CFR 211.160(b)(4)
Instruments, apparatus, et. al. not meeting specs
Cited by Roger F Zabinski
26 Aug 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Felix Maldonado, Meisha R Sampson, Tajah L Blackburn, Meisha R Waters
26 Aug 2015
21 CFR 211.160(b)(4)
Calibration - at intervals, written program, remedial action
Cited by Felix Maldonado, Meisha R Sampson, Tajah L Blackburn, Meisha R Waters
26 Aug 2015
21 CFR 211.188(b)(10)
Records of any sampling performed
Cited by Felix Maldonado, Meisha R Sampson, Tajah L Blackburn, Meisha R Waters
Investigators
FDA investigators tied to this site in the record.
Sandra A Boyd1 insp.
Joseph A Piechocki1 insp.
Youkeun Kim1 insp.
Rajiv R Srivastava1 insp.
Eileen A Liu1 insp.
Jose E Melendez1 insp.
Miguel A Martinez1 insp.
Roger F Zabinski1 insp.
Sandra A Hughes1 insp.
Junho Pak1 insp.
Marvin D Jones1 insp.
Felix Maldonado1 insp.
Meisha R Sampson1 insp.
Tajah L Blackburn1 insp.
Meisha R Waters1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Shilpa Medicare 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