Firm Record
Swiss Parenterals Limited findings history
2 findings from 2 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Aseptic processing and sterility assuranceComputer system validation
Published inspection documents
2026-04-17
EMA (Europe)
1 findingsComputer system validation Onsite inspection identified 7 critical and 9 major deficiencies. Critical deficiencies relate to: 1. The pharmaceutical quality system does not effectively encompass the specific requirements for sterile product manufacturing, as evidenced by inadequate deviation management and the lack of effective implementation of risk management and risk-based decision-making. 2. During the observation of production activities and review of selected smoke studies it was noticed that interventions were often poorly designed, and aseptic techniques, operators qualification, training, behaviour, and practices in many cases did not comply with the requirements of EU GMP Annex 1. 3. The manufacturer failed to supply the requested documentation promptly and transparently during the inspection. There are concern about authenticity and control of documentation, and there is insufficient assurance that records are attributable and contemporaneously generated. 4. Deficiencies were identified in the design of premises and equipment (including lack of appropriate barrier systems), handling of disinfectants, garment washing procedures, coverage of all processes during APS, omission of products from cleaning validation matrices, inadequate design of airflow visualisation studies, and absence of a validated procedure for CCIT of ampoules. 5. Inadequate equipment and process design for dispensing, sampling and blending, as well as inadequate design of manual interventions manual interventions related to handling of sterile powders. 6. Inadequate material transfer pathways and processes. 7. Inadequate OOS investigations. The major deficiencies are related to: pharmaceutical quality system, sanitary/hygienic practices, premises and equipment, production, quality control, qualification and validation, aseptic process simulation (media-fill), cleaning validation and cleaning practices, computerized systems.
Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. 530-10/24-06/07, 381-13-08/284-25-13 Current certificate 530-10/24-06/07; 381-13-08/284-25-13 will be withdrawn. Suspension of the marketing authorisation(s) Member States should consider not authorising marketing authorisation applications/variations to marketing authorisations with this site listed as a finished product manufacturing site until the non-compliance statement remains in place. Recall of batches already released Recall of medicinal products should be considered where potential quality defect has greater impact to public health than supply restriction in affected Member State(s). Prohibition of supply Following issuance of the final Statement of non-compliance with the principles and guidelines of GMP and as long as it remains in place, the prohibition of importation and/or supply from the site should be considered.
2026-04-17
EMA (Europe)
1 findingsAseptic processing and sterility assurance Onsite inspection identified 3 (three) Critical, 12 (twelve) Major and 2 (two) other deficiencies. The Critical deficiencies were related to: 1. The manufacturer failed to minimize risks from contamination associated with the direct human interventions in the critical zone (grade A) during aseptic operations related to the preparation of a sterile blend, and sampling and dispensing of sterile starting materials. Direct human interventions are performed under RLAF without any barrier system. The aseptic techniques/behaviour of the operators were also found not aligned with the requirements; 2. The manufacturer failed to implement adequate aseptic techniques and personnel behaviour, and failed to ensure sterility of disinfectants and garments used in grade A/B manufacturing areas; 3. The Pharmaceutical Quality System was not correctly implemented. A lack of adequate Quality Management oversight, recording, and investigation of all deviations individually or collectively, influences the quality of a product. The inspection team identified failures to ensure that all production deviations are reported, evaluated, and investigated, and the conclusions recorded, as multiple production deviations observed during inspection tours were unaddressed until inspectors informed personnel of the issues. Major deficiencies were found in the following areas: Material transfer in/out of clean areas across all production lines, Production area design and risks related to cross-contamination in Beta-Lactam production, The Contamination Control Strategy (CCS), Procedures for Aseptic Interventions and Aseptic Process Simulation, Cleanliness and maintenance of production facilities, Inadequate gowning and poor personnel hygiene practices, Premises and Equipment in clean production areas and maintenance, Visual Inspection and Container Closure Integrity Testing, Quality Control, Qualifications and Validations, Documentation control, and Computerised Systems.
Action taken/proposed by the NCA: Withdrawal, of current valid GMP certificate No. 530-10/24-06/08; 381-13-08/310-25-18 Current certificate 530-10/24-06/08; 381-13-08/310-25-18 will be withdrawn. Suspension of the marketing authorisation(s) Member States should consider not authorising marketing authorisation applications/variations to marketing authorisations with this site listed as a finished product manufacturing site until the non-compliance statement remains in place. Recall of batches already released Recall of medicinal products should be considered where potential quality defect has greater impact to public health than supply restriction in affected Member States. Prohibition of supply Following issuance of the final Statement of Non-Compliance with the principles and guidelines of GMP and as long as it remains in place, the prohibition of importation and/or supply from the site should be considered.
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 2026-09-03, 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.
