FDA 483 - avenue pharmacy inc. - December 06, 2019

During a recent inspection, the FDA issued a Form 483 observation to your firm regarding significant quality system and manufacturing issues. The primary finding was the observation of non-microbial contamination within your production area. This contamination was directly linked to ongoing construction in an adjacent area.

Specifically, the firm was found to have continued drug production operations concurrently with the construction activities without implementing adequate controls. These controls are critical to prevent the ingress of contaminants from the construction zone into the production environment and, subsequently, into the drug product itself. This deficiency indicates a failure to maintain appropriate environmental controls and segregation, which are fundamental requirements for Good Manufacturing Practices (GMP). The lack of adequate controls during concurrent construction and production poses a risk to product quality and patient safety due to potential contamination.