Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-14.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Nov 2025 – 14 Nov 2025 | Human Drugs | 483 | On file |
| 25 Apr 2024 – 3 May 2024 | Human Drugs | 483 | On file |
| 26 Feb 2018 – 6 Mar 2018 | Human Drugs | 483 | On file |
| 28 Jul 2016 – 5 Aug 2016 | Human Drugs | 483 | On file |
| 17 Sep 2015 – 25 Sep 2015 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
3 May 2024
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Anastasia M Shields, Justin A Boyd, Vaishali J Patel
3 May 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Anastasia M Shields, Justin A Boyd, Vaishali J Patel
3 May 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Anastasia M Shields, Justin A Boyd, Vaishali J Patel
3 May 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Anastasia M Shields, Justin A Boyd, Vaishali J Patel
3 May 2024
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Anastasia M Shields, Justin A Boyd, Vaishali J Patel
Investigators
FDA investigators tied to this site in the record.
Anastasia M Shields2 insp.
Lisa L Flores1 insp.
Jose E Melendez1 insp.
Angelica M Hernandez1 insp.
Justin A Boyd1 insp.
Vaishali J Patel1 insp.
Carrie A Hughes1 insp.
Jose A Cruz Gonzalez1 insp.
Kham Phommachanh1 insp.
Eileen A Liu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 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 | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind EUGIA Pharma Specialities Limited's 5 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