FDA Recalls & Cites AminoRip & PROTEINEX PRODUCTS.
www.aminorip.com
FDA investigation & CONSUMERS should note that MANUFACTURES FAILED INSPECTIONS, FAILED TO PROVIDE RECORDS AND DOCUMENTATION.
FDA Inspections, Compliance,
Enforcement, and Criminal Investigations:
“ Your firm failed to conduct testing of either every finished dietary supplement batch or a subset of the finished dietary supplement batches that you identify through a sound statistical sampling plan to determine whether the finished product meets established product specifications for identity, purity, strength, and composition of the dietary supplement, as required by 21 CFR 111.75(c).”
The U.S. Food and Drug Administration, or FDA, has just released a copy of its February 9th warning letter to Abba Pharma, Inc., which is the company behind Proteinex® and AminoRip®. Proteinex and AminoRip are a “pre-digested” protein supplement used for various purposes.
AND FURTHERMORE THE FDA FOUND THESE PRODUCTS ADULTEREATED DIETARY SUPLEMENT AND FAILED TO PROTECT YOUR SAFETY.
The FDA reported that Llorens Pharmaceuticals and BioMedical Sport Failed to provide adequate response and correction. The investigation is ongoing and no response has been made public at this time. We did attempt to contact both Llorens Pharmaceuticals and BioMedical Sport but both companies refused to respond to telephone calls or emails. No response tells a story of its own.
But the FDA alleges in their official warning letter to the company that folks who take Proteinex and AminoRip may be getting much more than they bargained for— mislabeling, misbranding, and adulterated dietary supplements and products.
The marketing of the product with these claims violates the Act. You may find the Act and FDA regulations through links on FDA's home page at http://www.fda.gov.
When the FDA tested, several Proteinex and AminoRip products it found phosphorus and potassium levels that were not declared on the products’ labels even though some of the products contained 400 mgs or more. Sodium levels that were misbranded and claims that could cause serious harm in the critically ill. The FDA called for an immediate Quarantine of all products but Lloren’s Pharmaceuticals and BioMedical Sport failed to do so.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm243567.htm
The FDA warning letter also gives a few details about an inspection that took place over several days in August of 2010. That inspection turned up what the agency is characterizing as “serious violations” of current FDA guidelines. The company’s response in regards to those allegations is—in the words of the agency—“inadequate” because the company did not really offer a plan of corrective action. Many of the allegations come down to plain old sloppy housekeeping but one of the FDA’s concerns jumped out at us. The company is accused of using water that they cannot guarantee is clean enough not to contaminate the supplements that contain it.
Proteinex is also accused of making unauthorized drug claims about several products on its website, www.llorenspharm.com. The folks behind Proteinex and AminoRip were given 15 working days to respond. As far as we can tell their response—assuming they have made one by now—has not been made public and no “close out letter” has yet been issued by the FDA. Therefore it can be assumed that the FDA is still pursuing an investigation into both companies and all products. Consumer and Buyer Beware.
Source:
FDA. (2011). Abba Pharma Inc. 2/9/11. Warning letter accessible at fda.gov/ICECI/EnforcementActions/WarningLetters/ucm243567.htm.
http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm243609.htm
Email us at: info@aminoripusa.com
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AminoRip & PROTEINEX PRODUCTS
- FDA CITED AND RECALLED
FDA REPORTS PROTEINEX & AminoRip; & the MANUFACTURES LLORENS PHARMACUTICALS & BIOMEDICAL SPORT are still under INVESTIGATION! |
