Drug factory · FDA FEI 3009883410
Eugia Pharma Specialities Limited
Unit - 2, A-1128 & B-1127, RIICO Industrial Area, Phase-III, Bhiwadi, India
Serious problems, FDA action at FDA's last inspection, Nov 14, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
6 drug inspections on record since 2015: 0 with no problems, 4 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ertapenem | Makes it, makes the active ingredient, tests it and packages it | AuroMedics Pharma LLC | 55150-282 |
| Meropenem | Makes it, makes the active ingredient, tests it and packages it | AuroMedics Pharma LLC | 55150-207, 55150-208 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 14, 2025 | Serious problems, FDA action | Drug Quality Assurance | — |
| May 3, 2024 | Serious problems, FDA action | Drug Quality Assurance | 7 |
| Jun 24, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 6, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 25, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 3, 2024 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. - Mfg / Processing Operations Area 21 CFR 211.42(c)(5)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
Mar 6, 2018 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Lab controls established, including changes 21 CFR 211.160(a)
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by the appropriate organizational unit. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
Registered with FDA for: analysis; api manufacture; manufacture; pack.