Glossary
Manufacturer
A person or company holding an authorisation to manufacture medicines under the applicable regulation.
Related sections
WHO TRS 986 Annex 2, Part 1 의약품 제조 및 품질관리에 관한 규정 [별표 1]
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Action taken/proposed by the NCA: Others The manufacturer did not previously have EU GMP certification.
EMA · EU GMP NCR (EudraGMDP) · 2024-03-07 -
Others Member states should consider not initiating or authorising new marketing authorisations with this site listed as a finished product manufacturer until the recommended non-compliance statement to be issued remains in place or is not superseded with a GMP certificate.
EMA · EU GMP NCR (EudraGMDP) · 2026-08-24 -
In response to Observation 1 of the Form FDA 483, you state that your investigation was extended to other batches and bulk drug samples were submitted to the manufacturer.
FDA · FDA Warning Letter · 2022-06-14
