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FDA CGMPs First Round of Inspection of Dietary Supplements Facilities–Lessons Learned

From Dietary Supplements e-Newsletter - May 2009

By Yoshiyuki Tokiwa, Maged Sharaf, and Gabriel Giancaspro

FDA published the final rule of Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (CGMPs) in June 2007. Compliance with the new CGMPs is mandatory from June 25, 2008, for companies with 500 or more employees; from June 25, 2009, for companies with 20 to 499 employees; and by June 25, 2010, all companies must comply with the new rule.

The first round of CGMPs inspections involved dietary supplement manufacturers, packers, and distributors with 500 or more full-time equivalent employees and mostly occurred during the third quarter of 2008. The Establishment Inspection Reports (EIR) and FDA Form 483, Inspectional Observations, for those inspections are available for review on the FDA/ORA Web site (www.fda.gov/ora/frequent/default.htm). Based on the available records (accessed May 8, 2009), following are some observations on the outcomes of those inspections:

  1. FDA inspectors looked into various stages of the manufacturing process.
  2. Companies previously inspected by FDA received a closer review of the issues that were noticed during previous visits.
  3. Some inspections lasted only one day, while others extended into several days and multiple visits.
  4. FDA Form 483s were issued for the following reasons:
    1. Deficiencies in documentation
    2. Poor hygiene practices
    3. Inadequate testing methodologies
    4. Failure to use appropriate scientifically valid methods
    5. Lack of test results for some specifications of ingredients
    6. Failure to demonstrate all requirements were met, as part of Master Packaging Records
    7. Malfunction in facilities

USP offers standards and services that help the dietary supplement industry meet the CGMPs requirements. The most notable include

  • Publications, including United States Pharmacopeia–National Formulary (USP–NF), USP Dietary Supplements Compendium (DSC), and Food Chemicals Codex, Sixth Edition (FCC). These include General Chapters, such as the <2750> Manufacturing Practices for Dietary Supplements, and standard monographs with specifications for dietary supplements, dietary ingredients, and other components of dietary supplements. Since its first publication in 1993, General Chapter <2750> has provided stringent quality requirements. These quality requirements have been implemented in the USP Verification Programs since the programs began in 2000.
  • Reference Standards: for botanicals, vitamins, non-botanicals, and other dietary supplement ingredients
  • The Dietary Supplements & Ingredient Verification Programs (more information is available; contact )