An Illinois OTC ophthalmic drug manufacturer failed to convince the Food and Drug Administration it was keeping contaminants away from a sterile processing line and was advised to conduct a comprehensive evaluation of the effectiveness of its environmental monitoring.
Sloppy Sterility Seen At US OTC Ophthalmic Firm
Mexican Sanitizer Maker Also Warned About Sterile Conditions, Halts Production
Sterling Pharmaceutical’s Restricted Access Barrier Systems “permitted access to the processing line … without the design of rigid wall enclosures,” FDA says. Eksa Mills makes cleaning solutions with the same equipment in same facility and didn’t maintain written cleaning procedures or equipment use logs.
More from Regulation
• By
Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.
• By
Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.
• By
Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.
• By
Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.
More from Policy & Regulation
• By
A round-up of the latest industry moves in Europe: Pharma Deutschland elects board of new Brussels operation; MHRA's new CEO gets to work; Futura names non-executive director.
• By
“If this doesn’t get reauthorized, look at the number of the ingredients out there, the number of products, what would happen all those products out there for the consumer, on that shelf, in the drugstore or someplace?” says Rep. Bob Latta during House hearing.
• By
Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. “If we reauthorize it, will it continue?” Texas representative Lizzie Fletcher asks of OMUFA.