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January 2, 2013

2 Min Read
Raca Enterprises Receives FDA Warning Letter over E. coli, other CGMP Violations

WASHINGTON FDA last month sent a warning letter to Raca Enterprises, Inc., dba Life Cycle Herbal Products, noting its products failed to met CGMP (Current Good Manufacturing Practice) requirements for dietary supplements.

The regulatory violations included shipping a dietary supplement lot over the summer that contained E. coli, an FDA official Alonza Cruse wrote in the Dec. 14 letter to the owners of the company.

In August, FDA inspected Raca's manufacturing facility in El Monte, Calif. Raca responded to the investigator's observations, but FDA claimed its responses including its response to the E. coli incident  were inadequate.

"You indicated that you had your retain sample for this product tested by a 3rd party laboratory to verify the E. coli test and that the results indicate the product was negative for E. coli. However, as noted above, this subsequent test was conducted several weeks after the product had been shipped, and at the time it was shipped your firm had a positive result for E. coli," Cruse wrote.

FDA also noted several other CGMP violations that included, but were not limited to, the following:

·        failure to create written procedures for the responsibilities of the quality control operations

·        failure to conduct a test or examination to verify the identity of a component that is a dietary ingredient prior to its use

·        failure to prepare and follow a written manufacturing record for each unique formulation of dietary supplement the company manufactures, and for each batch size

·        failure to prepare a batch record that includes complete information relating to production and control of each batch of dietary supplement the company manufactures

The agency acknowledged Raca had made some corrections to the investigator's observations, "including the maintenance of the physical plant in a clean and sanitary condition, as well as creating written procedures for in-process specifications for weight checks and executing those procedures to verify that specifications are met."

Raca was given the typical 15 days to respond to FDA's letter.

Companies who respond to the FDA following an inspection aren't always successful in alleviating the agency's concerns. For instance, in a Nov. 14 warning letter to AloeScience Labs, Inc., FDA cited a number of CGMP violations at its facility in Garland, Texas, and declared the company's response on April 12, 2012 to the investigator's observations were insufficient.

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