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Current Good Manufacturing Practice Violations at Worthing, UK Facility
Date: 10/07/2011 (Date of Warning Letter)
Misconduct Type: Health
Enforcement Agency: Health and Human Servs.
Contracting Party: None
Court Type: N/A
Disposition: Investigative Finding
Synopsis: The U.S. Food and Drug Administration (FDA) issued a warning letter to SmithKline Beecham Limited that it had violated Current Good Manufacturing Practice (CGMP) regulations at its manufacturing facility in Worthing West Sussex, United Kingdom. The FDA found that the company did not establish appropriate written procedures designed to prevent microbiological contamination of drug products purported to be sterile, failed to follow laboratory control procedures, and that the quality control unit did not adequately exercise its responsibilities to approve procedures or specifications that may impact the identity, strength, quality, and purity of the drug product.