The manufacturers failed to comply with requirements related to post approval studies and good manufacturing requirements, respectively.
Will more medical devices be impacted?
The agency found several violations during an inspection related to its investigation of inaccurate blood lead test results.
The agency has issued its list of the most common inspectional observations for FY 2017.
These violators have caused serious injury or death to patients. Here we focus on AM2PAT’s former president, Dushyant Mahendrabhai Patel.