The FDA has come down on an aseptic blow-fill-seal pharma manufacturing operating in Florida that the agency says has widespread issues with microbiological contamination.
The FDA posted a warning letter today that was issued last month to Horizon Pharmaceuticals following an inspection that dates back to the fall of 2015. The FDA said that when it inspected the company’s facility in Riviera Beach, Florida, it “found multiple deficient practices at (the) facility that pose a significant microbiological contamination risk.”
Among those was its cleaning and disinfection program, which it said didn’t use a sporicidal agent. The inspectors discovered the facility had shipped three lots of an ophthalmic drug even though some bottles which were tested were contaminated with Bacillus mycoides, which is a spore-forming microbe.
In addition, they found poor facility maintenance, like leaking pipes in the cleanroom ceiling, chipped and cracked floors in the batch tank room, and blue and black particulates as well as dust on tanks next to the ingredient charging ports.
It noted that an ophthalmic drug failed pouch integrity tests, but the plant didn’t do enough to determine why. It also said Horizon’s visual inspection and test methods for filled vials are inadequate because the company hasn’t shown that they can detect particulate consistently.
The agency acknowledged the company’s efforts to improve the situation but said it wasn’t enough to avoid problems in the future.