Law360, New York (February 16, 2016, 6:27 PM ET) -- Virbac Animal Health, a major manufacturer of supplements and drugs sold in pet stores and veterinary clinics, ran scientifically unsound product tests, didn't properly investigate hundreds of complaints and failed to ensure suitable storage of its merchandise, according to new warning letter that leads this week's roundup of FDA enforcement actions.
Virbac's 'Quality Culture' Criticized
The warning letter to France-based Virbac stemmed from a U.S. Food and Drug Administration inspection of a Missouri production site in late 2014. Inspectors acknowledged various improvements that Virbac apparently promised in response, but they called the proposed remedies insufficient and said that the company had failed to deliver on similar promises in the past.
"We remain concerned about quality practices and quality culture at your facility," FDA officials wrote in the letter released Tuesday. "We note that many of the observations from your previous inspection are repeat observations from several prior inspections after which you also asserted corrective actions would be implemented."
Virbac makes numerous products that are widely sold in pet stores, including its popular line of C.E.T. dental chews and its Allerderm line of skin therapies. It also manufactures prescription products, such as Iverhart chewables for heartworm prevention.
One of the FDA's allegations was that Virbac didn't adequately staff a quality control unit — something the company was previously chastised about during inspections in 2007, 2008 and 2010. The understaffed unit failed to prevent distribution of products that didn't meet specifications, investigate complaints and report manufacturing changes to regulators, according to the FDA.
Elsewhere, when company workers encountered out-of-specification test results, they sometimes just ran tests over and over again until they obtained passing results, according to the letter, which said there was "[no] scientific rationale for doing so." Although Virbac promised to revise its testing protocol, the FDA said that some of the problems could be blamed on failure to following existing protocol.
"In addition to revising your [protocol], you should take steps to ensure that your employees follow it," the warning letter said.
The letter also said that Virbac received 1,900 complaints in 2014 but only forwarded 21 of them to its quality unit. Of 30 complaints related to pet deaths, only two were forwarded.
Elsewhere, the FDA noted that Virbac's products must be stored in locations that aren't too hot or too cold in order to ensure quality. "You did not, however, have and follow written procedures to control and/or monitor the temperature in your warehouse areas," the agency wrote.
A spokesman for Virbac couldn't immediately be reached for comment. The discipline exacerbates existing headaches for Virbac, which was among several drugmakers that received warning letters last month over improper sales of levothyroxine tablets for canine thyroid problems.
Virbac's 'Quality Culture' Criticized
The warning letter to France-based Virbac stemmed from a U.S. Food and Drug Administration inspection of a Missouri production site in late 2014. Inspectors acknowledged various improvements that Virbac apparently promised in response, but they called the proposed remedies insufficient and said that the company had failed to deliver on similar promises in the past.
"We remain concerned about quality practices and quality culture at your facility," FDA officials wrote in the letter released Tuesday. "We note that many of the observations from your previous inspection are repeat observations from several prior inspections after which you also asserted corrective actions would be implemented."
Virbac makes numerous products that are widely sold in pet stores, including its popular line of C.E.T. dental chews and its Allerderm line of skin therapies. It also manufactures prescription products, such as Iverhart chewables for heartworm prevention.
One of the FDA's allegations was that Virbac didn't adequately staff a quality control unit — something the company was previously chastised about during inspections in 2007, 2008 and 2010. The understaffed unit failed to prevent distribution of products that didn't meet specifications, investigate complaints and report manufacturing changes to regulators, according to the FDA.
Elsewhere, when company workers encountered out-of-specification test results, they sometimes just ran tests over and over again until they obtained passing results, according to the letter, which said there was "[no] scientific rationale for doing so." Although Virbac promised to revise its testing protocol, the FDA said that some of the problems could be blamed on failure to following existing protocol.
"In addition to revising your [protocol], you should take steps to ensure that your employees follow it," the warning letter said.
The letter also said that Virbac received 1,900 complaints in 2014 but only forwarded 21 of them to its quality unit. Of 30 complaints related to pet deaths, only two were forwarded.
Elsewhere, the FDA noted that Virbac's products must be stored in locations that aren't too hot or too cold in order to ensure quality. "You did not, however, have and follow written procedures to control and/or monitor the temperature in your warehouse areas," the agency wrote.
A spokesman for Virbac couldn't immediately be reached for comment. The discipline exacerbates existing headaches for Virbac, which was among several drugmakers that received warning letters last month over improper sales of levothyroxine tablets for canine thyroid problems.