Sterile Drugmaker Warned for Facility’s Defective Design

The FDA issued a warning letter to AllerQuest for design flaws at its Plainville, Connecticut sterile drug manufacturing plant, including gaps in doors leading to sterile areas.

The agency’s investigators found an ISO 5 area, where ampules were aseptically filled, had double doors with multiple gaps adjacent to an unclassified area, posing a risk of air entering the critical area. The warning letter notes that the company tried to seal the gaps with tape during the inspection.

“Any area that adjoins and can impact an ISO 5 area should be appropriately designed, maintained and classified,” the agency said.