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Posted June 21, 2011

FDA Warns Laboratory of Manufacturing Violations

On June 10, 2011, the U.S. FDA posted a Warning Letter (dated 4/15/11) to Nutro Laboratories, a division of NBTY, Inc., concerning serious violations of the current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements based on its inspection of Nutro facilities in October 2010. The violations observed at the Nutro facility primarily related to the ingredient crospovidone, an excipient used in supplements.

The FDA noted the Nutro was notified on September 16, 2010, by its supplier that the component crospovidone contained high levels of peroxide, an impurity that can cause a finished product to be sub-potent. However, even after being notified about the high levels of peroxide, Nutro did not establish a purity specification for peroxide. In response to the observation, in October Nutro indicated that it would update its specification for crospovidone to include a test for peroxide with a specification of <400 ppm, as per the European Pharmacopoeia. However, the FDA found this inadequate because Nutro did not subsequently provide the FDA with any documentation to show that it updated the purity specification for this component. The FDA noted that its investigators collected a sample of Crospovidone lot# PKVX091027006 from Nutro’s inventory and the sample results revealed levels of peroxide greater than 400 ppm.

The FDA also noted that Nutro failed to establish the reliability of its supplier of crospovidone by establishing the reliability of the Certificate of Analysis (COA) through confirmation of the supplier’s test results.

In a related article in on June 21, 2011, NBTY’s president is quoted as saying “We were embarrassed [to receive the warning letter], but we have now made all of the proper corrections to our standard operating procedures to ensure that something like this doesn’t happen again. We have now addressed all of the FDA’s concerns.”

The FDA Warning Letter is available at the link below.