White Paper on Dietary Supplements

Final FDA Rule on Dietary Supplements (21 CFR Part 111)
<strong>White</strong> <strong>Paper</strong>
Benefits of customer complaint software: A customer complaint software solution automates the
process of documenting, reviewing and, when necessary, investigating customer complaints. The
process of investigating complaints is greatly expedited by the ability to launch a review/approval
routing (with all relevant documents attached). This prevents delays in resolving complaints due to the
paperwork not being complete.
Another benefit is that complaint records stored in secure, centralized electronic files can be easily
retrieved by authorized users. They can also be automatically retrieved by the system to print reports,
perform analyses, etc., which help companies to see trends and respond proactively.
In summary, an automated document control/management system and automated processes can help
assure quality and regulatory compliance, proper documentation, and greatly speed up the processes
involved in the production of dietary supplements.
References
1. FDA information about the recall can be found at the following URL, downloaded March 25, 2008,
from http://www.fda.gov/oc/po/firmrecalls/nasutra09_06.html
2.
FDA information about the recall can be found at the following URL, downloaded March 25, 2008,
from http://www.fda.gov/oc/po/firmrecalls/fiberchoice03_07.html
3. Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR)
Facts. Downloaded March 25, 2008, from the following URL: www.cfsan.fda.gov/~dms/dscgmps6.
html
4. Mei-Chih Lin, Yoe-Ray Ku, Yi-Chu Liu, Jer-Huei Lin. P-090: Isolation and Identification of a
novel Sildenafil analogue adulterated in herbal supplements. Bureau of Food and Drug Analysis,
Department of Health, Taipei, Taiwan. Retrieved: March 31, 2008 from http://www.phcog.org/
AnnualMtg/2006/papers/P_090.pdf
5. Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and
Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act. Downloaded on March 25, 2008, from http://www.
cfsan.fda.gov/~dms/dsaergui.html#def
6. Adverse event reporting form. Retrieved March 31, 2008 from the following URL: http://www.fda.
gov/medwatch/getforms.htm.
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