FDA EIR - Jost Chemical Co. - January 18, 2018
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A routine FDA inspection of Jost Chemical Co Inc, a manufacturer of inorganic salts used in dietary supplements, was conducted on January 18, 2018. The inspection, which focused solely on the dietary supplement operations, adhered to the HAFW2 FY18 work plans and specifically covered the regulatory framework for Dietary Supplements (7321.008A). This visit followed a previous inspection in August 2015, which had been classified as No Action Indicated (NAI). Significantly, the current inspection concluded without any noted deviations or issues. Consequently, no FDA-483, Inspectional Observations, was issued to Jost Chemical Co Inc. This indicates that the facility was found to be in compliance with the relevant regulations at the time of the inspection. At the inspection's conclusion, management, including President/CEO Jerry L. Jost and Laboratory Director John P. Gleason, was reminded of their general responsibility to ensure continued compliance with the Food Drug and Cosmetic Act. No specific corrective actions were mandated, given the absence of observed violations. The inspection included a review of various operations such as raw material receiving, production, quality control, warehousing, and analytical areas, along with pertinent Standard Operating Procedures and training documents.
ID · 9ea6bda6-539b-4bde-9661-0c1a4d37b782
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