AllerQuest Cited for Sterility, Air Control Concerns

The FDA issued a Form 483 to Plainville, Connecticut drugmaker AllerQuest for sterility issues and air control deficiencies after an inspection spanning from August to September.

The investigator found the firm could not provide assurance of positive air pressure control during manufacturing and it had been manufacturing under such conditions since 2014. In addition, processing areas lacked an adequate supply of air filtered through high-efficiency particulate air filters.

The firm failed to qualify a storage method for microbiological samples in a microbiology incubator and it did not demonstrate the impact on the airflow, temperature and humidity the containers had on incubated samples.