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Annual performance statistics report: July 2018 to June 2019

21 October 2019

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14. Pharmacovigilance inspection program (PVIP)

Table 79 Pharmacovigilance Inspection Program inspections undertaken and deficiencies identified
2017-18[a] 2018-19
July to June
Compliance investigation category
Total inspections completed 5 10
Total with completed findings 5 7
Critical deficiencies[b] 0 1
Major deficiencies[c] 25 34
Minor deficiencies[d] 12 24
Average deficiencies per inspection

0 critical

5 major

2 minor

0 critical

5 major

3 minor


Footnotes


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