Firm Record

VAKOS XT a.s. findings history

2 findings from 2 inspection documents published by regulators. Each row below says what its date means.

EMA (Europe) 2019-11-22 ~ 2019-11-22 2 documents 2 findings

Areas cited

Complaint and recall handlingComputer system validation

Published inspection documents

2019-11-22 EMA (Europe) 1 findingComplaint and recall handling Totally 25 deficiencies were found, 1 was classified as critical, 17 as major. Most of deficiencies was found on adjacent manufacturing site but some of them were common. 2 major deficiencies were found in the Quality Management - system of deviations and change control were not established. Other major deficiencies cover requirements on premises and equipment, e.g. storage rooms are not cleaned properly. Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. sukls78312/2017 in Full Withdrawal, of current valid GMP certificate No. sukls426470/2018 GMP certificates invalidated Recall of batches already released A recall of medicinal products should be evaluated by involved NCAs following the assessment. View the regulator's official source
2019-11-22 EMA (Europe) 1 findingComputer system validation Totally 25 deficiencies were found, 1 was classified as critical, 17 as major. The critical deficiency was related to premises: A mould was found on several places in the washing room. 2 major deficiencies were found in the Quality Management - system of deviations and change control was not established. 16 major deficiencies cover requirements on premises and equipment, e.g. production a storage rooms are not cleaned properly, dead insects were found in light covers in production rooms, walls and ceilings do not allow a proper cleaning. HVAC system is not set properly, a pressure drop leads from the room with the highest risk of contamination to production rooms. Microbiological monitoring is insufficient. Computerized systems in QC are not controlled. Cleaning validation was performed only formally. Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. sukls78312/2017 in Full This manufacturer should not be authorized in any new/ongoing marketing authorization or variation application. Withdrawal, of current valid GMP certificate No. sukls426470/2018 GMP certificates invalidated Suspension of the marketing authorisation(s) This manufacturer should not be authorized in any new/ongoing marketing authorization or variation application. Recall of batches already released A recall of medicinal products should be evaluated by involved NCAs following the assessment. 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.

Full history of VAKOS XT a.s. — including inspection classifications Browse by document Go to Findings search
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