Instant GMP Compliance for Dietary Supplements – What is the cost of Compliance?
The FDA calculated the price of Good Manufacturing Practices (GMP) whenever they 1st drafted the Dietary Supplement Health and Education Act (DSHEA). Dietary product GMP regulations, kratom near me eugene (watch this video) located in the Federal Register, cover everything estimated expenses, relating to compliance, that an organization would incur depending on small business size. The FDA believed that altogether dietary supplement makers will spend 56,000 hours as a one-time burden in creation of written procedures. Additionally, 930,000 hours was estimated as the sum total for all business enterprises to do sufficient record keeping. The FDA then used the data to estimate the economic impact for a variety of sized companies.
Small Establishments (Less than twenty employees with annual revenue under $1M)
Little Establishments
Set up Costs = $26,000
Yearly Costs = $46,000
Moderate Establishments (twenty – 500 staff with annual revenue of $5M – $10M)
Set up Costs = $20,000
Yearly Costs = $184,000