Skin - Johnson & Johnson Medical Pty Ltd , Johnson & Johnson Medical Pty Ltd, CON-1216
Product name
Skin - Johnson & Johnson Medical Pty Ltd
Sponsor name
Johnson & Johnson Medical Pty Ltd
Consent start
Consent no.
CON-1216
Standard
clause 15(1) of Therapeutic Goods (Standards for Biologicals-General and Specific Requirements) (TGO 109) Order 2021
Non-compliance with standard
The products, FlexHD does not conform with clause 15(1) of TGO 109 that specify
the biological starting material must be collected from the donor within 24
hours of asystole.
Therapeutic product type
Prescription medicines