The warning letter addressed several quality assurance violations identified at the company, including incomplete follow through on product complaints.
“We have worked very hard in tandem with the FDA to develop and implement a plan that will keep Anika at an exemplary level with respect to compliance. We appreciate all of the cooperation that we received from the Agency to aid in our progress,” Anika’s CEO, Charles H. Sherwood, PhD, said in the release.
Read the release on Anika Therapeutics.
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