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Prismic Light GMP Missteps Earn Another Warning Letter
July 18, 2012
3 Min Read
NASHVILLE, Tenn.FDA found numerous GMP (good manufacturing practice) and labeling violations at Prismic Light International, a dietary supplement company that received a warning letter from FDA in 2008 related to health claims. In a June 28, 2012, warning letter to owner Timothy M. Sanders, DDS, FDA also said the company had labeling issues and again, it was cited for health claim issues.
FDA inspected Prismic Light's Murfreesboro, TN, facility on Jan. 18 and 19, and 23, 2012, and after finding various GMP violations, issued a Form 483 on Jan. 23,2012.
GMP Violations
FDA found several GMP violations during its inspection. Prismic Light did not have master manufacturing records (MMRs) nor did it have documentation to show it had quality control (QC) procedures, according to FDA. The agency also found the company failed to
Keep incoming raw material separate from finished products
Establish product specifications (The company estimated ingredients that went into formulas without accurately measuring them, causing finished products to vary in strength and composition.)
Conduct tests to verify the identity of dietary ingredients
Prepare batch production records (BPRs)
Hold samples of each lot of dietary supplements
Maintain written procedures for equipment
Calibrate instruments or ensure the equipment functions
Keep records for cleaning the plant and for pest control
Establish procedures to respond to product complaints
Establish procedures for returned dietary supplements
Product Claims
FDA reviewed the company's websites sandentco.com and prismiclight.com in June 2012, and determined some products were promoted for conditions that cause the products to be drugs because they were marketed for use in the diagnosis, cure, mitigation, treatment or prevention of diseases.
FDA found the company's Cell Renew and Cell Silver products were promoted as fighting bacteria, viruses, fungi and parasites. The company also called out specific ingredients and made drug claims for them, according to FDA. For instance, the company said copper (which is in Cell Silver) "will cause Parasites to leave the system," and said zinc (also in Cell Silver) "stops viral and bacterial replication"
Label Issues
FDA's inspection also found labels of several products misbranded products. For instance, the agency reported individual trace minerals, amino acids, enzymes and dietary ingredients in the proprietary blend used in Cell Renew, Cell Renew Essential Silica and Cell Silver were not declared on the Supplement Facts panel.
Other labeling violations included:
The Cell Silver product label did not segregate dietary ingredients into separate sections of the Supplement Facts panel.
The Cell Silver product label did not declare the amount of copper or zinc in each serving or the percent of the Daily Value.
Labels for Cell Renew and Cell Silver list ingredients such as "Purified water" and "dissolved oxygen" inside the Supplement Facts panel. However, these ingredients must be listed immediately below or to the right of the nutrition label.
Cell Renew Essential Silica, Cell Renew and Cell Silver failed to identify the products using the term "dietary supplement."
Cell Renew Essential Silica and Cell Silver products failed to include a domestic address or phone number to report serious adverse events.
INSIDER's Take:
Once a company is on FDA's radar, as Prismic Light was from the 2008 warning letter, FDA will continue to watch it for similar and other violations. Here, the company was slammed for more than claim violations. FDA inspected the facility and company website and found GMP, labeling and product claim issues.
A company that has already received a warning letter from FDA should make sure it follows all the ruleseven those it didn't violate before. That would be the best way to ensure the company doesn't receive another warning letter. Hoping FDA will forget is not an option.
Learn from Prismic Light's and other company's mistakes in the INSIDER Slide Show: Top 10 Warning Letter Lessons.
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