Findings library

One deviation finding a week, taken apart

Written from the deficiency categories regulators publish, not from named reports. Each entry shows the observation in the inspector's style, why it was cited, and the practice that would have prevented it.

MajorModule 4 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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MajorModule 5 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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MajorModule 6 1 Sept 2026

Closed on day 30, investigated on day 45

Deviation handling: investigation not completed before closure

Of 40 deviations reviewed, 11 had been closed on or before the 30-day target with investigation sections marked 'to be completed'. In 6 cases the investigation was completed after closure and appended without re-approval. No extension requests were on file. The site's deviation metric reported 100% on-time closure for the period.

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MajorModule 1 25 Aug 2026

A 'planned deviation' that lasted eleven months

Change control: changes implemented through the deviation system

Planned deviation PD-23-014 authorised the use of an alternative mixing speed for product X 'pending completion of the change control'. The planned deviation was approved by the production manager and had been extended four times over eleven months. No change control had been raised. Process validation had not been assessed for the altered parameter.

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OtherModule 6 18 Aug 2026

Forty deviations, no trend, no pattern seen

Pharmaceutical quality system: trending and management review

The site's deviation system contained 40 deviations from packaging line 2 in the review period, of which 14 related to label reconciliation. Each had been investigated individually and closed as minor. No trend analysis by failure mode had been performed. The product quality review recorded the count of deviations but did not identify the recurrence.

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