Instant GMP Compliance for Dietary Supplements – What’s the price of Compliance?
The FDA calculated the price of Good Manufacturing Practices (GMP) whenever they first drafted the Dietary Supplement Health and Education Act (DSHEA). Dietary supplement GMP regulations, located in the Federal Register, kratom near me colorado springs co, simply click the next web page, cover all estimated costs, associated with compliance, that a company would incur based on small business size. The FDA estimated that altogether dietary supplement manufacturers would invest 56,000 hours as an one time burden of creation of written methods. Additionally, 930,000 hours was estimated as the sum total for those companies to conduct proper record keeping. The FDA then used the data to estimate the economic impact for various sized companies.
Small Establishments (Less than 20 employees with annual revenue under $1M)
Small Establishments
Set up Costs = $26,000
Annual Costs = $46,000
Moderate Establishments (twenty – 500 personnel with annual earnings of $5M – $10M)
Moderate Establishments
Set up Costs = $20,000