Altaire Pharmaceuticals drew a 31-page Form 483 from the FDA for numerous failures related to contamination, laboratory controls and cleaning.
An agency inspection revealed “clearly turbid” sterility samples that the firm’s quality unit failed to investigate.
Altaire was also cited for having deficient controls to prevent contamination or mix-ups, and for not fully following procedures to prevent microbiological contamination of products that were supposed to be sterile.
In addition, the agency cited the firm for not maintaining its equipment at appropriate intervals to prevent contamination. The investigator noted a pressure gauge attached to a condenser unit that had condensation inside and what appeared to be a black liquid.
The facility was also written up for deficient laboratory controls. Specifically, it lacked proper test procedures to ensure that products met identity, strength, quality and purity standards.