Tag Archives: Defect Management

Serialization Challenges of Track & Trace in the Biopharma Industry

10% of drugs sold around the world are fake.  Counterfeit medicines are the cause of on average 1 million deaths yearly.  Increasing of online purchases and disrupted supply chains have intensified and made the risk of counterfeit medicines due to COVID-19. Drugs are “tracked” once after the product has left the manufacturer and landed where…
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Sagent Pharmaceuticals, Inc. Issues Nationwide Recall

November 19, 2021, Sagent Pharma announces a voluntary nationwide recall of Levetiracetam Injection.  Four lots of Levetiracetam was recalled due to the lack of a sterile product.  Issues pertaining to container closure integrity was brought to attention when found in reserve sample vials.  Sagent Pharmaceuticals did not follow USP suggested guidelines for container closure integrity—distributing…
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Keys to a Successful Rapid Commercial Launch

In manufacturing, pharmaceutical companies’ drugs are produced in hopes to save patients as fast as they can.  It is a “race to the finish” pharmaceutical online stated.  Getting the drug products produced and sent out to patients as fast as possible is every manufactures goal. The third highest number of drug approvals in over twenty…
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ICU Medical, Inc. Amino Acid Injection Recall

Particulate matter was found in an Amino Acid Injection in September.  ICU Medical, Inc. voluntarily recalled one lot of Aminosyn II, 15% of 2,112 units.  This is a Sulfite Free IV solution used in hospitals.  The recall was enforced due to particles such as fibers, hairs and proteinaceous materials.  These particles were found when ICU…
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