Transmission of Malaria by Blood Donors - FDA updates Guidance Document
As a result of the specifics of the pandemic situation over the past two years, the FDA is issuing an update to its recommendations for reducing malaria transmission during transfusions. It replaces the April 2020 guidance.
FDA Information on bacterial Contamination of Platelets for Transfusion
After 2019 and 2021, the FDA will again update its findings and recommendations regarding bacterial contamination of platelet preparations for transfusion purposes.
Warning Letter and Recall of a homeopathic Medicine for Children
FDA sends warning letter to the manufacturer of a homeopathic honey product, among other things because of microbiological contamination with Bacillus spec. Due to the advertised use for children, there was a not insignificant risk..
In May 2022, the US FDA inspected an Indian sterile manufacturer, revealing numerous deficiencies that have now led to a Warning Letter. Among other things, deficiencies in media fill, plant and cleanroom design, and environmental monitoring were cited.
Expert Task Force issues new Version of CCS Guideline
With the publication of the final version of the revised Annex 1 in August, the ECA Foundation's CCS Task Force got together again to update the CCS Guide based on the final Annex 1 version. The new CCS Guide version 2.0 now comprises the revision of quoted passages, the modification and insertion of individual sections and tables as well as an improved clarity and the update of the attachments.
Cross Contamination in Steam Steriliser at US Sterile Manufacturer
In October, the US FDA issued a Warning Letter to a US sterile manufacturer due to numerous GMP violations. The inspection, which had already taken place from March to April 2022, had revealed numerous deficiencies. The main reasons for the Warning Letter were cross contamination and microbiological contamination of products.
Sterile Product Manufacturing Process: Warning Letter to Texas Longhorn
After incomplete processing of defects listed in a 483, the Austin-based compounding manufacturer Texas Longhorn received a Warning Letter from the FDA.
Warning Letter to US Manufacturer of Sterile Medicinal Products - Part 2
Particulate contamination and inadequate aseptic working techniques while performing interventions during production once again led to a serious Warning Letter from the FDA. What did the FDA criticise and what did it demand from the American company Cangene BioPharma, LLC dba Emergent BioSolutions?
Warning Letter to US Manufacturer of Sterile Medicinal Products - Part 1
Particulate contamination and inadequate aseptic working techniques while performing interventions during production once again led to a serious Warning Letter from the FDA. What did the FDA criticise and what did it demand from the American company Cangene BioPharma, LLC dba Emergent BioSolutions?
PIC/S also publishes revised Annex 1 (Manufacture of Sterile Medicinal Products)
Almost simultaneously with the EU Commission, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) also published the revised Annex 1. What is the background?
After more than five years and two public drafts for comment, the European Commission this week published the final version of the new EU GMP Annex 1 "Manufacture of Sterile Medicinal Products". Learn more about deadlines and changes compared to the 2nd draft version for comment from 2020.
FDA draws consequences for poor quality of hand disinfectants and UV Wands
In the follow-up to the pandemic situation, the FDA is still reviewing the manufacture and importation of hand sanitizers and identifying potentially critical hand sanitizers. This is shown by the warning letter issued to Guangzhou Orchard Aromatherapy & Skin Care Co.