Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-27.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Feb 2026 – 27 Feb 2026 | Human Drugs | 483 | View 483 → |
| 17 Jul 2023 – 26 Jul 2023 | Human Drugs | Clean | |
| 19 Aug 2019 – 28 Aug 2019 | Human Drugs | 483 | View 483 → |
| 4 Jun 2018 – 8 Jun 2018 | Human Drugs | Clean | |
| 7 Dec 2017 – 14 Dec 2017 | Human Drugs | Clean | |
| 28 Aug 2017 – 1 Sep 2017 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Feb 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Matthew B Casale, Joseph A Piechocki
27 Feb 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Matthew B Casale, Joseph A Piechocki
27 Feb 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Matthew B Casale, Joseph A Piechocki
27 Feb 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Matthew B Casale, Joseph A Piechocki
Investigators
FDA investigators tied to this site in the record.
Matthew B Casale1 insp.
Joseph A Piechocki1 insp.
Sangeeta M Khurana1 insp.
Carolina D Vasquez1 insp.
Roger F Zabinski1 insp.
Marcus A Ray1 insp.
Zhaoyang Meng1 insp.
Sony Mathews1 insp.
David D Anderson1 insp.
Constantin Y Philopoulos1 insp.
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 | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind EUGIA Pharma Specialities Limited's 2 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