FDA finds potentially dangerous drug issues at Floriday specialty pharmacy
Months after tainted steroid shots made by a Massachusetts specialty pharmacy triggered the worst drug disaster in decades, federal inspectors have found dozens of potentially dangerous safety problems at about 30 other specialty pharmacies, known as compounders.
Among the lapses discovered by Food and Drug Administration inspectors were “black particles of unknown origin” in seven vials of a sterile injectable steroid at a Florida company. Elsewhere, they found rust and mold in “clean rooms,” inadequate microbial testing, even tears in gloves worn by technicians — all practices that create the risk of possible deadly contamination.
An FDA spokesman said the investigation of the Florida pharmacy is ongoing and that officials do not know what the black particles are.
The inspections, which were conducted between February and April, marked the first time that the FDA targeted compounders since inspectors found filthy conditions at the Massachusetts pharmacy at the heart of the fungal meningitis outbreak. The “priority inspections” were aimed at compounders who make high-risk sterile products, a key segment of the multibillion-dollar compounding industry that has fallen between the regulatory cracks.
Last fall, the FDA found “greenish black foreign matter” in vials of steroid shots at NECC that was later determined to be a culprit in the outbreak that has killed 53 people and sickened 680 others.
FDA officials say the problems highlight continuing sterility failures at compounding pharmacies despite months of stepped-up scrutiny from state and federal regulators and consumer groups.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.
- White House breach ‘a cry out for help,’ alleged intruder’s ex-wife says
- Beads in beauty products called toxin
- 32 structures destroyed in California’s King wildfire
- NYC’s High Line completed, culminating 15-year effort
- Man seen with UVa student faces driving charge
- Mentally ill Pa. man might go free in 9/11 scare
- Legislators urge Secret Service to reassess White House security
- U.S. confident it’ll have allies for airstrikes against ISIS
- Officials say too many in the 18-64 age range skip flu vaccination
- March around the world seek to put focus on climate change
- Woman gives birth on California freeway shoulder