Vials of a U.S. drugmaker’s product tested positive for bacteria, underscoring the company’s lack of sterility controls, the FDA says.
An inspection of an Amniotic Therapies facility found the company lacked procedures to prevent microbiological contamination of biological drug products, according to an FDA warning letter.
The FDA highlights the company’s failure to test the sterility of its products, which were linked to four adverse events, including two infections from Mycoplasma hominis, and positive tests for M. hominis.
Furthermore, the company neglected to conduct environmental monitoring as an added sterility assurance measure, although it claims on its website that its products undergo sterility tests and are sterile.
The manufacturing processes of its products have not been validated either, the FDA says, noting the lack of established protocol to ensure the company’s products have the appropriate identity, strength, quality, and purity.
The FDA recommends that the company take prompt corrective action to mitigate the potential for contamination.
Read the warning letter here: www.fdanews.com/08-30-16-AmnioticTherapies.pdf.
What do you need to know and do prior to your pre-approval inspection? Get the answers in FDAnews’ step-by-step guide, Preparing for an FDA Pre-Approval Inspection.