FDA 483 - Village Compounding Pharmacy - March 31, 2017

An FDA inspection was conducted at Village Compounding Pharmacy in Houston, TX, from March 20 to March 31, 2017. The inspection resulted in the issuance of a Form FDA 483, detailing two significant observations related to the production of sterile drug products, indicating deficiencies in current Good Manufacturing Practices (GMP).The primary observation noted that the firm utilized non-sterile wipes for disinfecting a laminar airflow hood during the aseptic production of a sterile injectable drug product, Prostaglandin 500 MCG/ML. This practice compromises the sterility of the processing environment and the finished product.A second observation highlighted the presence of a potential source of microbial contamination within the cleanroom. An unsterile item was observed approximately five feet from the aseptic processing hood, posing a direct risk to the sterility of sterile drug products compounded in that area.These observations signify critical lapses in maintaining an aseptic processing environment, which is essential for ensuring the safety and quality of sterile medications. Village Compounding Pharmacy is required to respond to the FDA 483 by discussing any objections or submitting a plan for corrective actions to address these identified issues.