FDA Chides Sterile Drugmaker for Product Contamination

Injectable sterile drug manufacturer Pharmaceutics International received a Form 483 for its failure to adequately investigate particulates in products and conduct design inputs for its combination product.

During a July inspection of Pharmaceutics’ Cockeysville, Md., facility, the FDA found the drugmaker initiated eight deviation investigations for batches of zoledronic acid injection that were rejected due to the presence of fibers and particles.

“Five of the eight investigations failed to identify the characteristics of the fiber/particle rejects, or determine the source of the fibers/particulates, “according to the form that cites 16 observations.

The drugmaker also found a high percentage of fibers in four submission batches of zoledronic, but the manufacturer again failed to determine the source of the fibers.

The agency also chided Pharmaceutics for failing to install procedures for design controls for zoledronic acid injection, which is a combination product due to its luer lock syringe system. Design inputs for the combination product weren’t documented, and there were no design review meetings conducted for the product, the FDA said.

In addition, the company’s design validation study didn’t take into account pharmacy technician as a potential end user, despite the instructions for use not prohibiting pharmacy technicians from preparing the product, the form reads.

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