FDA cites sanitary issues at specialty pharmacies

(AP)—The Food and Drug Administration says it has uncovered troubling sterility problems at 30 specialty pharmacies that were inspected following a recent outbreak of meningitis caused by contaminated drugs.

The agency said its inspectors targeted 31 compounding pharmacies that produce sterile drugs, which must be prepared under highly sanitary conditions.

In an online posting Thursday, the FDA said it issued inspection reports to all but one of the pharmacies listing problems, including: rust and mold in supposedly sterile rooms, inadequate ventilation and employees wearing non-sterile lab coats.

The inspections were conducted between February and April in response to a deadly fungal linked to contaminated steroids. The injections from a Massachusetts pharmacy have caused 53 deaths and 733 illnesses since last summer.

0 shares

Related Stories

FDA finds contamination concerns at Ameridose

date Nov 12, 2012

(AP)—Federal health inspectors have found more than a dozen sterility problems, including insects, at a drugmaking facility with the same founders as the specialty pharmacy linked to a deadly meningitis outbreak.

FDA chief renews push for specialty pharmacy rules

date Dec 19, 2012

(AP)—The head of the Food and Drug Administration renewed her push for new rules to help police pharmacies like the one that triggered a deadly meningitis outbreak, even as members of Congress expressed little interest ...

Consumer watchdog asks FDA to revisit compounders

date Nov 29, 2012

(AP)—A government watchdog group is calling on the Food and Drug Administration to re-inspect more than a dozen specialty pharmacies with prior records of violations, in light of a recent deadly outbreak tied to compounded ...

Senate questions pharmacy boards after outbreak

date Nov 19, 2012

(AP)—A Senate committee investigating a deadly outbreak of meningitis wants to know how regulators in all 50 states oversee specialty pharmacies like the one that triggered the illness.

Recommended for you

Breastfeeding protects against environmental pollution

date May 22, 2015

Living in a city with a high level of vehicle traffic or close to a steel works means living with two intense sources of environmental pollution. However, a study conducted by the UPV/EHU researcher Aitana ...

When it comes to hearing, diet may trump noise exposure

date May 22, 2015

Although the old wives' tale about carrots being good for your eyesight has been debunked, University of Florida researchers have found a link between healthy eating and another of your five senses: hearing.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.