Regulatory Focus™ > News Articles > Repeat Deficiencies Form Basis of Warning Letter to Veterinary Pharmaceutical Manufacturer

Repeat Deficiencies Form Basis of Warning Letter to Veterinary Pharmaceutical Manufacturer

Posted 13 December 2012 | By

A number of recurring deficiencies form the basis of a warning letter sent to a St. Louis veterinary drug manufacturing facility.

The company, Performance Products Inc (PPI), was accused of "significant deviations of Current Good Manufacturing Practice (CGMP) regulations" in the 20 November 2012 letter. PPI manufactures a number of products aimed at bovine and equine species, with most of those products being probiotic in nature.

The company's website boats about its "highly concentrated combination of host specific live bacteria, enzymes and yeast which are specially blended to aid digestion and improve your animal's health," and notes that all of its products contain "naturally occurring bacteria."

What PPI's facilities did not contain, FDA alleges, were policies sufficient for it to meet US regulations. Inspectors said they were unable to access certain batch production, equipment cleaning or product stability records. "In fact," FDA wrote, "during the inspection your Vice President stated that your firm would not provide batch records, laboratory records or product stability testing records for Triton Purrge Drops and Biozide Gel."

"We … request you refrain from refusing to allow FDA investigators access to records which they lawfully have authority to inspect and copy," the agency wrote, implying that the company had withheld the records in question illegally.

FDA noted that this same violation had also happened during an April 2011 inspection of the same facility. "This is a recurring observation," FDA wrote. The warning letter goes on to make that same observation-in bolded typeface-three additional times, referencing inspections conducted in April 2011, June 2006, September 2005, September 2003 and July 2001.

Those repeat observations included the company failing to perform identity testing on materials used in the manufacture of its products, a lack of written testing procedures to assess stability characteristics and the strength of its products, and a lack of validation for its cleaning procedures.

Several of the firm's products-at least three, including its Biozide Gel Wound Dressing-are misbranded as a result of the label failing to identify the exact species of animal which the drug is indicated for, FDA alleged. Another two products-Triton Purrge Drops and an un-named product-are currently marketed "without approved applications or index listings," FDA said.

"You should be aware that, while we are not taking action against your products on this basis at this time, unapproved products that lack a required application or index listing are subject to FDA enforcement action to remove them from the market at any time," FDA explained.

Regulatory Focus has reached out to Performance Products Inc for comment and will update this story with their comments should we hear back.


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