Best Formulations Inc – FDA EIR, Sep 30, 2021

An FDA inspection of Best Formulations Inc, a contract manufacturer of dietary supplements and animal drug products, occurred from September 27-30, 2021. The inspection, conducted under Compliance Program 7371.001 (Animal Drug Manufacturing Inspections), reviewed compliance with 21 CFR 211 for drug production, encompassing Quality, Production, Materials, Facilities, Equipment, Laboratory Control, and Packaging/Labeling Systems. Although the firm discontinued Vitamin K-1 Gel Capsules production in 2018, it maintains its drug manufacturer registration. The inspection resulted in a single FDA-483 observation: the firm lacked established and followed written procedures for cleaning and maintaining equipment used in drug product manufacturing. Specific issues included uncleaned tanks with unknown residues, absence of cleaning logs for these tanks, and improperly labeled scrap product. Additionally, cleaning activity records were incomplete. Management acknowledged these findings, committing to implement corrective actions such as creating cleaning logs for equipment, proper labeling of leftover materials, and ensuring sanitary production conditions. Further discussions highlighted six areas of concern: absence of a procedure for manual HPLC data integration, operators not signing batch records concurrently with task performance, pest control deficiencies in the finished product warehouse, insufficient detail in the SOP regarding glove usage for soft gel handling, uninvestigated temperature/humidity excursions, and an inadequate investigation SOP that lacked comprehensive root cause analysis and preventative action requirements.