June 11, 2012
PHILADELPHIA FDA found numerous cGMP (current good manufacturing practice) and health claim violations after inspecting the Himalayan Institute of Buffalo's liquid supplement manufacturing facility and after reviewing the company's website , according a warning letter the agency send to company president Rolf Sovik on May 24, 2012.
FDA visited the Buffalo, NY, facility on Jan. 4, through Jan. 18, 2012, and found the following cGMP violations, according to the letter:
Himalayan Institute of Buffalo did not have a written master manufacturing record (MMR) for each batch size of dietary supplement it manufactures.
The company did not conduct identity testing of dietary ingredients.
It did not verify a suppliers certificate of analysis (CoA) by conducting its own identity test.
It did not establish specifications for identity, purity, strength or composition of finished dietary supplements. It also did not have specifications for labeling or packaging its products.
The company failed to quarantine raw materials before it started the manufacturing process
It did not include required information in MMRs for several of its products, including information on identity and weight of each dietary ingredient on the Supplement Facts label; a statement of theoretical yield of a dietary supplement expected at each stage of the manufacturing process; a description of packaging and a representative label; written instructions for sampling procedures; and corrective action plans for when a specification is not met
It also failed to include required information in its batch production records (BPRs), such as the identity of the equipment and processing lines used; date and time of the maintenance, cleaning and sanitizing equipment and processing lines; the identity and weight each component; a statement of the actual yield and a statement of the percentage of theoretical yield; documentation that the finished dietary supplement meets specifications; documentation of the manufacture of the batch such as signatures of operators who weighed and verified batch components; documentation of packaging and labeling operations; and documentation of quality control (QC) review.
It failed to establish and follow written procedures for QC operations
It did not have records of written procedures for laboratory operations, including written procedures for the tests it conducted to determine whether specifications are met.
It did not have written procedures to review and investigate product complaints
It did not establish written procedures for handling returned dietary supplements.
The company also failed to routinely inspect its manufacturing machines, and did not have records of this process.
FDA also reviewed himalayaninstitute.org and found claims that promoted products for conditions that cause the products to be drugs. FDA said the name of the product Inflam-away implies it reduces inflammation. Other questionable claims FDA pointed to said products have been used to treat eczema, psoriasis, arthritis, depression, heart disease and cancer.
FDA also found the company made unapproved nutrient content claims on its website. Specifically, the webpage titled "Namastea Black (225g Bag)" included the claims, "Black tea is recognized for its rich concentration in antioxidant polyphenols such as EGC, EGCG, and other flavonols . . . ." and Loaded with protective antioxidant polyphenols." The terms "rich concentration" and loaded with" denote nutrient content claims. However, FDA said no RDI (reference daily intake) has been established for polyphenols, EGC, EGCG or Flavonols and thus, these are unauthorized nutrient content claims.
Further, the Adapt-a-gem product was misbranded, according to FDA, because it said it contains ginseng, but the ingredient is not from a plant classified within the genus Panax. The ingredient statement for the company's product lists Siberian Ginseng (Eleutherococcus senticosus). According to law, the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax.
FDA also noted The Adapt-a-gem and the Cholesta-low did not carry the Supplement Facts panel, and the Cholesta-low product did not list the ingredient He Shou Wu root by the common or usual name.
Himalayan Institute of Buffalo's may have been operating under many more GMPs that it seems by reading the warning letter, but because the company did not write them all down, FDA says it didn't happen. The dietary supplement industry can again take the message that writing specifications and procedure down is crucial to passing a GMP inspection.
In this case, FDA also looked at Himalayan Institute of Buffalo's website for claims, and found some were illegal for dietary supplements. This shows once FDA is vetting a company on-site, it's also going online. FDA will review everything it can about a company in one sitting, so it makes sense for brand owners to keep compliant on all fronts.
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