Drugs

2014 Baxter FDA-483 Released

David McFarland

— 1 min read
Share

FDA has just released the FDA-483 with five observations from a 1/7-1/23/14 inspection at Baxter Healthcare in Cleveland, OH. Specific observations on the form were: 

  •          the quality control unit lacks the responsibility and authority to reject all drug products;
  •          control procedures are not established that validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
  •          routine calibration and inspection of electronic equipment is not performed according to a written program designed to assure proper performance;
  •          establishment of the reliability of the component supplier’s report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals; and
  •          the quality control unit lacks responsibility to approve all procedures or specifications affecting the quality and purity of drug products.

Read more