Home » Inadequate Sterility Investigations Cited in Cardinal Health 483
Inadequate Sterility Investigations Cited in Cardinal Health 483
September 8, 2009
Cardinal Health did not adequately investigate sterility failures of three batches of product and did not have documentation on notification or follow-up on the failures with nuclear pharmacies that received the product, violating standard operating procedure (SOP), a Form 483 says.
To View This Article:
Subscribe To Drug GMP Report
Drug GMP Report Subscription
A one-year subscription to Drug GMP Report (DGR) provides thorough analysis and interpretation of ever-changing U.S. and international good manufacturing practice (GMP) regulations, FDA enforcement trends, warning letters and more. Each monthly issue is packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.
In each issue you get professionally researched, fully vetted, expertly written articles by our experienced staff for the kind of quick-read monthly update you need to stay current — without having to waste a minute of your busy work day on unproductive internet searches.
PLUS: in every issue, you get links to additional documents that support DGR’s articles, such as draft and final guidances, 483s and warning letters, proposed rules, closeout letters, full text of proposed legislation, and many others.
There’s absolutely no risk to you. You get our 100% Money-Back Guarantee: If at any time, for any reason, you become dissatisfied with Drug GMP Report, you may cancel your subscription and receive a full refund. No questions asked.
So, why wait? Become a subscriber to Drug GMP Report today. It couldn’t be easier.