Venus warning letter belies poor 483 response

A belief in FDA rubber-stamping any company response to inspection findings is perhaps the most likely explanation behind the warning letter to a dietary supplement maker. The letter, posted recently to the FDA website, shows that despite such distractions as a top-level reorganization, an unblinking congressional stare, and a major revamp in the medical device center, FDA inspectors are focused and on the job.

Warning Letter NYK-2011-10 was issued in May to CEO Bharat Kakumanu at Venus Pharmaceuticals in Hauppauge, NY. In the warning, the agency references responses made by the company to the Form 483 description of inspectors' findings during their visit. The company is expected to reply to the form.

Some matters end there--when the manufacturer submits thorough, well-reasoned and complete responses that assure the regulator the GMP violations are being treated not just seriously, but with the utmost urgency at the highest levels of the company. However, among the reasons warning letters are issued are responses that indicate the company has given insufficient attention to the violations, doesn't care about them, needs additional direction, or is simply flouting FDA authority.

The Venus warning leaves open all four possibilities. The manufacturer's responses appear to have been assembled quickly, with little care--and with little insight into FDA expectations. In fact,  the majority of the violations are in fundamental areas.

Lack of master manufacturing records and incomplete batch production records lead the list. In the 483 response, the company included samples of its new batch production records, but something was missing. "While you have the fields for information, the fields must be filled in with all the necessary information for the specific production batch that is being manufactured," the letter states. "Submitting just the form that you intend to use does not adequately address the violation," the letter adds in regards to the company's response to a citation for its lack of raw material testing.

"Your firm did not conduct finished product testing," the letter also states. This time the company had included a blank form labeled "Finished Product QC Report." It provided no indication of the tests to be done or the specs to be met.

- here's Warning Letter NYK-2011-10