Companies with the most findings
Recent findings
UK MHRA
NORGINE LIMITED
2026-08-03
An inspection of the site was conducted from 05 to 08 May 2026. Two critical deficiencies and three major deficiencies from GMP were raised. The critical deficiencies concerned the failure to implement a comprehensively designed and correctly implemented PQS incorporating GMP and QRM, evidenced by the failure to ensure that robust and reliable batch control procedures were in place, as well as the failure of the Qualified Persons to ensure that each individual batch had been manufactured and checked in compliance the requirements of GMP.
Action taken/proposed by the NCA: Action taken/proposed: suspension in full Withdrawal of current valid GMP certificates: UK MIA(IMP) 322 INSP IMP 322/14798-0031[I]
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UK MHRA
NORGINE LIMITED
2026-08-03
An inspection of the site was conducted from 05 to 08 May 2026. Two critical deficiencies and three major deficiencies from GMP were raised. The critical deficiencies concerned the failure to implement a comprehensively designed and correctly implemented PQS incorporating GMP and QRM, evidenced by the failure to ensure that robust and reliable batch control procedures were in place, as well as the failure of the Qualified Persons to ensure that each individual batch had been manufactured and checked in compliance the requirements of the MA and GMP. This Statement of Non Compliance does not include the manufacture of critical products. Such products should be agreed in writing with individual National Competent Authorities.
Action taken/proposed by the NCA: Action taken/proposed: suspension In part Withdrawal of current valid GMP certificates: UK MIA 322 INSP GMP 322/14798-0030[H] Prohibition of supply: Only batches of critical products can be supplied to UK markets while this statement of non-compliance remains in force.
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US FDA
Aptuit Ltd
2026-07-28
The identity of each raw material of drug substance is not verified by conducting at least one test to | verify the identity , using specific identity test.
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US FDA
Aptuit Ltd
2026-07-28
Procedures designed to prevent microbiological contamination ofproducts purporting to be non-sterile | are not established.
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US FDA
Aptuit Ltd
2026-07-28
The accuracy, sensitivity, specificity, reproducibility, and reliability of microbiological test methods has not been established.
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US FDA
Aptuit Ltd
2026-07-28
The responsibilities applicable to the quality unit are not fully followed.
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These findings are a record of the moment each document was published. 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 them as the current state; check the regulator's official announcements for the latest status. Counts are measured from public data as of 2026-09-04, and findings are extracted automatically from the regulator's published documents. “View official source” on each case links directly to that document.
