Firm Record

DISHMAN CARBOGEN AMCIS LIMITED findings history

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

EMA (Europe)US FDA 2018-12-10 ~ 2020-04-20 2 documents 4 findings

Areas cited

Other quality systemCleaning validationDeviation, CAPA, and investigation

Published inspection documents

2020-04-20 EMA (Europe) 1 findingsCleaning validation During the joint Swissmedic / EDQM inspection 1 critical, 7 major and 11 other deficiencies were identified. The critical deficiency is related to an insufficient QA oversight leading to a situation that constitutes a potential risk of producing products which could be harmful to the patient. The firm's approach on materials management, including the labelling, traceability, storage conditions, dispensing, cleaning, pest control of raw materials, intermediates, solvents and recovered solvents was considered as not in compliance with EU GMP. The company failed in multipurpose facility/ies to mitigate the risks of cross-contamination and was not aware of the necessary measures to be taken before introducing a new chemical entity in the sampling, dispensing and synthesis area. A lack of effective maintenance and/or cleaning resulting in rust and dirt in hardly cleanable premises in the distillation plant, manufacturing Unit 3A and 3B and in the drum and storage area were obvious. The recovery of solvents in the distillation plant was not properly managed and documented. Shortcomings were observed with regard to the process validation activities related to Dihydrotachysterol. No cleaning validation was performed in the multipurpose intermediate manufacturing Unit 3C despite highly active material (Progesteron) was handled. The identified critical and major deviations pose a risk for all manufactured intermediates and APIs in the multipurpose plant except for manufacturing Unit 9 (see section 3 Additional Comments). Action taken/proposed by the NCA: Suspension of the marketing authorisation(s) This manufacturer should not be authorised in any new/ongoing marketing authorization or variation application. The submission of a variation application for introducing alternative manufacturers of the active ingredient is recommended. Recall of batches already released (Separate Rapid Alert to follow) The decision to be made by NCA, following an assessment between the NCA and MAH, whether to recall a batch of a particular product or not should be based on a risk assessment and on the criticality of the product. Prohibition of supply After issuance of the non-compliance report and as long as it remains active, prohibition of supply of APIs (except APIs manufactured in Unit 9 – see below) is recommended, unless there are no alternative suppliers and there is a risk of shortage. Several critical products will be concerned. Therefore, while qualifying alternative APIs suppliers for critical products, the MAH(s) are requested to perform risk assessments in order to establish measures – agreed by their NCA - to mitigate risks associated with the GMP deficiencies observed (e.g. full specification testing etc.). Suspension or voiding of CEP (action to be taken by EDQM) Suspension or withdrawal of CEPs is recommended. 2018-12-10 US FDA 3 findingsDeviation, CAPA, and investigation · Other quality system Laboratory investigations for OOS intermediate batches are not conducted.

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.

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