FDA Sends Warning Letter To Miami University Contract Testing Laboratory For Poor QC And Faked Data
May 18th, 2022 // 2:21 pm @ jmpickett
A Miami University contract testing lab received an FDA warning letter last month for not ensuring that drugs were tested appropriately and preventing data from being altered or deleted.
According to the FDA warning letter sent on April 20, the agency stated that the contract testing laboratory’s Department of Biochemistry and Chemistry didn’t follow cGMPs as it did testing the various raw materials to produce heparin, which is important to stop and treat blood clots. The FDA warning letter followed an FDA inspection the agency did in November 2021.
Next, FDA pointed out that a customer performed an audit and found a college student analyst had faked data and provided arbitrary numbers. Also, the department didn’t closely monitor who had access to important data. The department responded that such a data falsification incident never happened before and that the manipulation of data wasn’t done to make the results meet requirements.
FDA responded that a dearth of conclusive data for any of the reported elements suggests the drug product is not being analyzed effectively for ideal pharmaceutical quality. Also, the system suitability characteristics show the results are unreliable. They also are not reportable and don’t support heparin drug quality.
FDA also criticized the department for lacking an effective QC unit or QS system in place to offer the correct oversight of lab operations. Right before the FDA audit, the department quickly put QC procedures in place. But FDA found this also happened after lab test results had been used to justify releasing drugs on the open market.
Miami University responded this month that it’s working on a response to the agency.
FDA also sent a copy of the letter to Smithfield Bioscience, which was the customer that the agency mentioned in the warning letter. That firm produces APIs and medical device parts made from heparin raw ingredients.
