Findings library

One inspection finding a week, taken apart

What the inspector wrote, why it was cited, and the two or three controls that would have prevented it. Written for the people who have to fix it.

MajorChapter 1 15 Sept 2026

'Human error' accepted as a root cause, again

Investigation of anomalies: inadequate root cause analysis

Deviation DEV-24-0187 concluded that the root cause was operator error and the CAPA was retraining of the operator concerned. The same failure mode had been recorded in three previous deviations in the preceding fourteen months, each with the same conclusion and the same corrective action. No assessment of contributing factors, procedure design or equipment had been performed.

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MajorChapter 1 8 Sept 2026

The impact assessment that stopped at the batch

Deviation handling: impact on other batches not evaluated

A temperature excursion in cold store CS-02 was recorded as a deviation against batch 4471 only. Twelve other batches of four products were stored in CS-02 during the excursion window. No assessment of impact on these batches was performed and two of them were subsequently certified and distributed.

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MajorChapter 4 1 Sept 2026

Shared logins on a GMP system

Computerised systems: data integrity, access control

The chromatography data system in QC laboratory 2 was accessed using a shared account 'QCLAB' whose password was known to all analysts. Electronic signatures applied under this account could not be attributed to an individual. The audit trail showed 214 result approvals under the shared account in the review period.

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MajorChapter 1 25 Aug 2026

The change that went live before anyone approved it

Change control: change implemented prior to approval

Change control CC-24-031 to replace the filling machine PLC was raised on 14 March and approved on 2 April. Maintenance records show the PLC was replaced on 21 March and production resumed on 22 March. Three batches were manufactured on the modified equipment before the change control, including its validation impact assessment, was approved.

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CriticalChapter 6 18 Aug 2026

Retested before anyone investigated

Quality control: OOS results not investigated in accordance with procedure

An assay result of 88.2% (specification 95.0 to 105.0%) for batch 7702 was obtained on 3 May. The sample was re-prepared and re-injected the same day, giving 97.1%, which was reported on the certificate of analysis. No laboratory investigation was opened until 9 May, after the batch had been certified. The original result was not referenced in the batch record.

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