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Musculoskeletal Tissue - Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria, The Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria, CON-1068
Product name
Musculoskeletal Tissue - Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria
Sponsor name
The Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria
Batches
The consent is limited to the 237 non-compliant allografts specified in the submission dated 20 February 2023.
Consent start
Consent no.
CON-1068
Duration
The consent is effective from 23 February 2023 until 23 February 2027.
Standard
clause 24(a)(ii) of TGO 109 of Therapeutic Goods (Standards for Biologicals-General and Specific Requirements) (TGO 109) Order 2021
Non-compliance with standard
The biologicals were not stored at the required storage temperature for
approximately 3.5 hours.
Conditions imposed
The consent is limited to the 237 non-compliant allografts specified in the
submission dated 20 February 2023.
Import, Supply, &/or Export
supply
Therapeutic product type
Blood, tissues, and biologicals