Northern VA Compounders PLLC, dba Akina Pharmacy

Warning LetterOpen

Bassem W. Girgis President Northern VA Compounders PLLC, dba Akina Pharmacy 23475 Rock Haven Way, Suite 105 Sterling , VA 20166-4444 United StatesFEI 3012590153Issued Apr 12, 2024Office of Pharmaceutical Quality

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012590153.

Violations2

Issue DateApr 12, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Northern VA Compounders PLLC, dba Akina Pharmacy
Location: Bassem W. Girgis President Northern VA Compounders PLLC, dba Akina Pharmacy 23475 Rock Haven Way, Suite 105 Sterling , VA 20166-4444 United States
FEI Number: 3012590153
Country: United States
Issue Date: April 12, 2024
Issuing Office: Office of Pharmaceutical Quality
Product Type: Drugs
Status: Open

Summary

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.

Northern VA Compounders PLLC, dba Akina Pharmacy FDA Warning Letter, April 12, 2024