Following an onsite inspection carried out between 4th to 8th October 2024 at Maxheal Pharmaceuticals (India) Ltd, the inspection team registered 2 critical and 5 major deficiencies, amongst a number of others, namely: data integrity issues, failures in cross-contamination containment measures, ineffective implementation of an adequate and good documentation system, systematic absence of training throughout the company, inadequate qualification and approval of suppliers, and failures in artwork control and in encapsulation operations, amongst others. Action taken/proposed by the NCA: Suspension of the marketing authorisation(s) Member States should consider refraining from initiating or authorizing marketing authorization applications that list this site as a finished product manufacturing site until the recommended non-compliance statement is issued and remains in place. Others Withdrawal of MT/032HM/2022
Inspection Record
Maxheal Pharmaceuticals (India) Limited — EU GMP NCR (EudraGMDP) Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
1Data integrity
About this record
Extracted automatically from the document EMA (Europe) published on 2024-11-12. The source is available at the link above.
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.
Translation and classification are automated and may differ in nuance from the source.
