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# 2014 Baxter FDA-483 Released
- URL: https://www.fdaweb.com/2014-baxter-fda-483-released/
- Published: 2017-12-14T12:00:00.000Z
- Updated: 2026-09-14T23:08:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140350

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.