FDA documents compliance issues at 15 more compounding facilities

Mar 13, 2013

The New England Compounding Center isn't the only compounding pharmacy with compliance issues. The FDA recently released the inspection details (form 483) of 15 compounding pharmacies in 12 states.

The New England Compounding Center isn't the only compounding pharmacy with compliance issues. The FDA recently released the inspection details (form 483) of 15 compounding pharmacies in 12 states.

During inspections, the FDA noted an average of about 7 observations for most pharmacies. But a total of 13 observations were made during the three days of inspection Feb. 20-22 at PharMEDium Services in Cleveland, Miss.

Observations made at PharMEDium included issues with: air filtration; laboratory testing of drug products; sterile processes; lack of the establishment of sterile procedures; poor maintenance of facility buildings, equipment and utensils; container closure systems and protection; written stability program for drug products.

The FDA also observed that PharMEDium's "written production and process control procedures are not followed in the execution of production and process control functions," according to the form.

"Also, we noted an employee dragging a full trash bag across the clean room floor with laminar air flow hoods located on each side where aseptic processing activities occurring," the investigators wrote on the form.

On each of the 483 forms, it is printed that the observations made by the FDA during the inspections "do not represent a final Agency determination" regarding the compliance of the pharmacies.

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