Cerebral Health fails FDA GMP inspection
In a letter dated May 23, FDA cited seven significant violations, including failure to prepare and follow a written master manufacturing record, failure to establish product specifications, failure establish identity specifications for the components used, and a failure to prepare and keep batch production records.
The warning letter, available here, follows an inspection of the company’s Jupiter, FL supplement facility from February 8-18, 2011.
“FDA acknowledges receipt of your response letter to the FDA 483 dated February 22, 2011, in which you stated that you were in the process of having the manufacture of ‘all of [your] bottled products’ outsourced to ‘GMP compliant contract manufacturers’,” states the FDA letter.
“Although not mentioned in your response letter, the timeframe you verbally gave to our investigator for completing this corrective action was within the next six months (i.e., mid-August 2011). Your response is inadequate in that you provided us with no information about your firm’s manufacturing operations in the interim,” it adds.
“You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction.”
