The FDA has scolded a Singapore maker of eye washes and other consumer products for poor manufacturing processes as well as for selling products in the U.S. that the FDA has never approved.
In a warning letter sent this month to Opto-Pharm and posted Tuesday to the FDA website, the agency said it would be a good idea for the company to hire a consultant, given the kinds of problems investigators uncovered during an inspection last year of the company’s manufacturing facility in Singapore.
Investigators said that Opto-Pharm during aseptic production had noted “numerous leaking containers and other bottle formation defects,” but shipped products anyway. This raised questions about whether the company’s products were, and will, remain sterile. It also pointed out that Opto-Pharm employees were reusing some items in manufacturing that should have been discarded after a single use.
On top of that, the company wasn’t conducting stability studies for its buffered saline and other ophthalmic solutions produced in 2014 and 2015, leaving open the question of whether the products would remain sterile throughout their expiration date.
The FDA said that the company’s Buffered Eye & Skin Xpect and Buffered Eye & Skin First Aid Direct products had not gone through the FDA approval process before being sold in the U.S.