FDA 483 - Buffalo Pharmacies Inc - July 26, 2018

An FDA inspection of Buffalo Pharmacies Inc., a producer of non-sterile drug products, was conducted from July 23 to July 26, 2018. The inspection resulted in an FDA Form 483 being issued to General Manager Alec Gillies. The main violation observed was the company's use of a non-pharmaceutical grade component in the formulation of a drug product. Specifically, an ingredient (redacted in the document) was utilized by a compounding technician on July 24, 2018, for the production of suppositories, and was also identified for use in Nystatin Vaginal suppositories. This observation highlights potential deviations from the regulatory framework of Current Good Manufacturing Practices (cGMP) concerning the quality and suitability of components used in drug manufacturing. While these are inspectional observations and not a final determination of compliance, Buffalo Pharmacies Inc. is required to evaluate these findings, investigate the root cause of using non-pharmaceutical grade materials, and implement robust corrective and preventive actions to ensure all drug product components meet appropriate quality standards, thereby safeguarding product efficacy and patient safety.