Firm Record
Eugia Pharma Specialities Limited findings history
61 findings from 9 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Aseptic processing and sterility assuranceLaboratory and QC controlsDeviation, CAPA, and investigationOther quality systemEquipment and facilityMaterial and supplier controlProcess validationDocumentation and recordsContamination controlQuality unit oversightTraining and personnelData integrityCleaning validationStability and storageComputer system validation
Published inspection documents
2026-10-19
US FDA
9 findingsQuality unit oversight · Aseptic processing and sterility assurance · Material and supplier control · Laboratory and QC controls · Process validation · Equipment and facility The responsibilities and procedures applicable to the Quality Unit are not fully followed. View the regulator's official source
2026-04-29
US FDA
4 findingsLaboratory and QC controls · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. View the regulator's official source
2026-03-27
EMA (Europe)
1 findingData integrity A follow up inspection was conducted on 25–27 February 2026 to verify the implementation of corrective actions from the previous inspection and to assess the current state of GMP compliance at the manufacturing unit responsible for producing the Meropenem active substance. Several critical deficiencies previously identified remained uncorrected, and additional critical and major deficiencies were observed, collectively demonstrating that the quality of the active substance is compromised and leading to the issuance of this NCR. Critical deficiencies from the previous inspection persisted. Glove integrity checks on the mobile LAF (PB/LAF23) were not performed consistently during operations, despite video evidence showing occasional verification. The LAF and RABS doors in room PB032 showed degradation and breaches, failing to ensure segregation between cleanroom grades. Furthermore, no monitoring of pressure differentials between Grade A and Grade B was in place, as the manometer measured only blower to filter pressure, leaving no evidence of appropriate environmental control in this critical area. Additional critical deficiencies were identified. The risk assessment QRM/EU2/061/2025 did not evaluate the need for revalidation of the Meropenem API manufacturing process following the installation of new RABS and modification of the filling line layout. Material and component transfer into Grade A/B areas was not demonstrated to follow a unidirectional and continuous process, as the mobile LAF was removed mid operation to retrieve additional containers, contradicting the company’s previous CAPA commitments. The cleaning of the filling line bin in PB032 was performed inside the room using a non closed, non automated process, with excess water drained into a bucket placed in front of the RABS, posing a significant contamination risk. Several major deficiencies were also identified. Change controls were not classified according to criticality, including those previously deemed critical. Procedures lacked clarity regarding definitions, responsibilities and operational steps, including the Change Control SOP and the SOP governing fingerprint access authorisation. The risk assessment did not clearly determine whether updates to the Batch Manufacturing Record were required. In Quality Control, no complete and updated analyst qualification matrix was available. Analyses assigned in LIMS to one analyst were performed by another, indicating non compliance with work allocation. QC logbooks lacked traceability and sequential documentation, with missing audit trails for key activities. Equipment status identification was inconsistent with LIMS records, and calibration responsibilities were not aligned with defined procedures. In the microbiology laboratory, an environmental monitoring sample was not provided in a timely manner, and critical temperature monitoring points in incubators were not identified. Maintenance of technical areas and utilities was inadequate. Replacement filters were stored in damaged and dirty boxes; ducts and insulation associated with AHU28 were degraded; the pre filter cleaning station and RO water pipe showed dirt and corrosion; and the pre filter inside AHU028 supplying PB32 appeared dirty despite recorded cleaning. Overall, the persistence of unresolved critical deficiencies, combined with newly identified critical and major findings, demonstrates a failure to ensure the required level of control for sterile API manufacturing. These deficiencies compromise the quality of the Meropenem active substance produced at this unit and justify the issuance of this NCR.
Action taken/proposed by the NCA: Prohibition of supply Due to the number and severity of the deficiencies identified, the supply of finished products manufactured with the Meropenem active substance produced at Eugia Unit II should be prohibited. Portugal will conduct a full identification of all medicinal product batches containing Meropenem API manufactured at this unit, in order to proceed with their recall. View the regulator's official source
2026-02-12
US FDA
11 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Laboratory and QC controls · Quality unit oversight · Training and personnel 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. View the regulator's official source
2025-10-21
Health Canada
10 findingsDeviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Other quality system · Stability and storage · Contamination control · Material and supplier control Investigations into deviations, reports, and/or follow-up actions were inadequate. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. View the regulator's official source
2024-08-20
US FDA
3 findingsDocumentation and records · Aseptic processing and sterility assurance Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). You failed to ensure records for equipment cleaning, disinfection, and sterilization are complete and accurate. For example, operators documented in production records for three batches of sterile injectable drug products that the stopper (b)(4) bowl and cap (b)(4) bowl for your (b)(4) were… View the regulator's official source
2024-05-13
US FDA
7 findingsAseptic processing and sterility assurance · Contamination control · Other quality system · Deviation, CAPA, and investigation Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. View the regulator's official source
2024-02-13
US FDA
9 findingsAseptic processing and sterility assurance · Process validation · Other quality system · Documentation and records · Computer system validation · Laboratory and QC controls · Deviation, CAPA, and investigation Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile did not include adequate validation of the aseptic process. View the regulator's official source
2023-06-26
Health Canada
7 findingsMaterial and supplier control · Aseptic processing and sterility assurance · Cleaning validation · Equipment and facility · Laboratory and QC controls · Other quality system The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material. View the regulator's official source
About this page
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
What is included. As of 2026-10-20, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.
Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.
