The FDA chided OTC drugmaker Altaire for an inadequate response to numerous customer complaints of mold in the eye drop product carboxymethylcellulose sodium 0.5 percent ophthalmic solution, 30 mL.
The complaints led to a recall in September of nine lots due to concerns regarding the effectiveness of the preservative after use and handling of the product by consumers.
Altaire attributed the mold to product drying on internal container surfaces during consumer use. However, the agency questioned whether the preservative used in the product’s formulation would be effective under consumer-use conditions.
The FDA said that the consumer opens the product’s container multiple times, which increases the potential for product drying.
The agency also said Altaire did not perform trending and evaluation for follow-up of the adverse event reports it received, including one associated with the mold problem.
During the inspection, investigators also noticed that birds were entering a space above the facility’s drop ceiling. Altaire placed steel wool in the space as a barrier, but it did not appear to work, the FDA said. Management told the agency that the birds haven’t found their way into manufacturing areas, but this isn’t a new issue, the form reads. A prior investigation found bird activity on the inside of roll-up doors and droppings on an electric panel in the packaging area.
Altaire Pharmaceuticals said it submitted “in a timely manner an appropriate response and we covered all the observations in that response.”
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