Notice of Drug Quality Sampling Inspection of Shandong Provincial Drug Administration (No. 8 of 2020)

No.
23 (2020)

In order to strengthen drug quality supervision and ensure the safety of public use of drugs, in accordance with the annual sampling inspection work plan of the Provincial Food and Drug Administration, the provincial bureau has conducted random inspections of drug quality on drug production, operation, and use units.
The situation of non-compliant drugs found in random inspections is hereby notified as follows :

1.
After verification and confirmation, 14 batches of drugs of 12 varieties from 10 manufacturing enterprises (preparation units) have been marked, and they do not meet the standard requirements after random inspection
.

2.
Relevant drug regulatory authorities have adopted control measures such as seizures, seizures, suspension of sales, and product recalls for non-compliant products, and have strictly investigated and dealt with relevant production enterprises (preparation units) and sampled units in accordance with relevant laws and regulations.
Check the relevant municipal market supervision and administration website
.

3.
For non-compliant products and corresponding production and operation enterprises and units, the relevant drug regulatory authorities shall strengthen supervision, supervise them to find out the cause of the problem, formulate and implement rectification measures, and effectively eliminate hidden risks
.

Hereby inform
.

Attachment 1: List of 14 batches of non-compliant drugs (Phase 8).
xls

Attachment 2: Small knowledge of non-compliance items (Issue 8).

Shandong Provincial Drug Administration

December 10, 2020

(Disclosure attribute: Active disclosure)