The inspection team identified 25 deficiencies against EU GMP. Of these, one was classified as critical and found in the area of data integrity controls in the QC laboratory. In addition, five deficiencies were classified as major and related to controls regarding product release from the site, contamination risks arising from inadequate maintenance and cleaning of equipment, buildings and facilities, records of GMP activities, out-of-specification investigations in the QC laboratory, and cleaning validation. The remaining 19 deficiencies were classified as other. Action taken/proposed by the NCA: Prohibition of supply After issuance of the non-compliance report and as long as it remains active, the site should not be authorized to distribute active ingredients for pharmaceutical use. Suspension or voiding of CEP (action to be taken by EDQM) EDQM withdrawal of CEP 2007-054 – Paracetamol
Inspection Record
Liaoyuan City Baikang Pharmaceutical Co. Ltd. — 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 2024-03-06. 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.
