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Northern VA Compounders PLLC, operating as Akina Pharmacy, was warned for producing adulterated drug products under insanitary conditions that posed patient safety risks. During a November-December 2022 inspection, FDA investigators identified serious deficiencies in manufacturing practices, including preparation of drug products under conditions that could contaminate them with filth or render them injurious to health, violating section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act. The company voluntarily recalled all lots of sterile drug products produced in December 2022 due to lack of sterility assurance after receiving FDA's inspection observations.