What changed at SSA in February, and what the company will not say about it
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
TheCompound Journal
Reporting on incretins, compounding & the peptide supply chain
The Supply Chain Dispatch
Reported from the analysis, not from a warning notice.
The health authority in Denmark has issued a warning on falsified exenatide injection pens found in the legitimate supply chain. The Journal has reviewed the notice and the accompanying photographs; the distinguishing features are a batch-number font difference and a needle-shield colour, neither of which a patient could reasonably be expected to detect.
Comparison of 12 certificates supplied by the reseller against the laboratory’s public archive matched 3 of them to reports commissioned by other parties, in some cases more than a year earlier. The reseller did not respond to two written requests for comment.
Comparison of 12 certificates supplied by the reseller against the laboratory’s public archive matched 3 of them to reports commissioned by other parties, in some cases more than a year earlier. The reseller did not respond to two written requests for comment.
The document is the weakest link in this trade. A certificate is a PDF; a laboratory letterhead is an image; a lot number is a string. Nothing in the ordinary transaction allows a buyer to confirm that a given report was issued for a given vial, and the four independent services differ in whether they offer any lookup at all.
Rowena Ashcombe, community pharmacist and diabetes educator, said the underfill finding was the more consequential one. "Nobody is being poisoned by a low content figure. Everybody using that vial is out by a fifth in every calculation they make."
The Journal has referred the cloned document to the laboratory named on it and has asked all four independent services whether they will offer a public report-number lookup. Two have replied.
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
The observation that closes a facility is rarely the dramatic one.
The Journal does not treat a badge as evidence and states so wherever it reports one.
Bacterial endotoxin is a heat-stable lipopolysaccharide from the outer membrane of Gram-negative organisms. It survives sterilisation, passes a sterilising filter, and is…
Documentation practice is the only part of vendor quality a buyer can assess before purchase.
Reported from the analysis, not from a warning notice.