The San Francisco facility is part of Thermo Fisher’s global pharma services network of more than 15 locations supporting cell and gene therapies.
The company is addressing these observations
The Congress gathers the whole value chain of the pharmaceutical industry on June, 12-13, 2023 in Switzerland
The observations are procedural in nature
The company will be submitting the responses to US FDA observations within stipulated timeline
The inspection concluded with no observations
New GMP facility for clinical and small-scale commercial pharmaceutical lipids
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
Resomer used in commercial 3D-printed implants for both soft and hard tissue applications
This order is subject to initial advance payment as per the agreed terms of the contract and this order will be executed within 6 to 8 months.
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