FDA warns compounding pharmacy, finds wood in drug sample

The discovery of adulterated products and insanitary conditions prompted FDA to send a warning letter to a compounding drug facility run by ImprimisRx earlier this month.

The discovery of adulterated products and insanitary conditions prompted FDA to send a warning letter to a compounding drug facility run by ImprimisRx earlier this month. An inspection of the Folcroft, PA, facility last summer found that "fibrous material consistent with wood was present in the sample taken from one of those lots of your product," FDA said. Inspectors also concluded that the compounding pharmacy's "cleaning and disinfecting procedures for work surfaces and utensils used for beta-lactam products are inadequate." According to FDA, the company stopped producing formulations with powdered penicillin and/or related beta-lactam ingredients, effective November 10, 2016. "Your action adequately addresses our concerns and such commitment will be verified during a follow up inspection," FDA said.