PET Drugmaker Gets 483 for Lack of Detail and Hairnets

June 14, 2013

Cardinal Health, which manufactures positron emission topography (PET) drugs at a Tampa, Fla. plant, received a Form 483 for thin investigations into batch failures.

During a February to March inspection, investigators found that most of the non-conformance investigations performed in 2012 had shortcomings.

“The investigations reviewed during this inspection did not contain detailed root cause assessments or corrective/preventative actions designed to minimize the chance of future recurrence of the same discrepancy,” reads the form, which contains four observations.

The FDA cited examples of investigations into production runs that resulted in radiological activity below specification and investigations into microbial growth on settling plates during sterility testing.

Investigators were also concerned about cleaning procedures and practices for the company’s hot cell, a shielded chamber designed to handle radioactive materials.

The drugmaker’s gowning practices also came under scrutiny. Cardinal doesn’t require the use of hairnets during cleaning of the hot cell and surrounding areas, according to the FDA.

It stands to reason that, in order to produce a drug as pure as possible, your equipment must be working properly. Thus, the better you monitor your equipment, the better your batches will turn out. That’s the idea behind Equipment Maintenance, Calibration And Cleaning: A Guide To FDA Inspections. So sign up today.