FDA EIR - Formulated Solutions, LLC - August 29, 2019

The U.S. Food and Drug Administration (FDA) conducted a comprehensive inspection of Formulated Solutions, LLC, a contract manufacturer of prescription, over-the-counter (OTC) drugs, cosmetics, and medical devices, from August 26 to August 29, 2019. The inspection specifically targeted drug manufacturing operations under the regulatory framework of current Good Manufacturing Practices (21 CFR 210/211) and the Federal Food, Drug, and Cosmetic Act. The scope covered the company's quality, production, materials, and laboratory systems. Remarkably, the inspection concluded without the issuance of an FDA Form 483, indicating no significant violations were observed. However, a verbal discussion was held with company management concerning the general nature of certain warehouse Standard Operating Procedures (SOPs), specifically SOP-WH-0001 and SOP-WH-0004. In response, Formulated Solutions' management committed to revising these SOPs to include more detail and agreed to apply this feedback broadly to enhance the clarity of other operational procedures.