Wednesday, January 25, U. These problems include failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs did not meet their specifications; failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date. The government also determined that Ranbaxy submitted false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed. Among other things, the consent decree prevents Ranbaxy from manufacturing drugs for the U. Once the consent decree is approved by the court, it becomes a court order with which Ranbaxy must comply or face contempt.
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Here we will address consent decree agreements between FDA and several pharmaceutical companies based on repeated failures to adequately address CGMP deficiencies. It is not an action taken on the basis of a single form , or a single warning letter. Generally, a series of events play out over time when critical inspection observations are not addressed and are identified in subsequent inspections.
Frequently one or more warning letters are involved. Often these firms are required to use a 3rd party consultants to perform lot release. Firms operating under a consent decree agreement have largely lost their independence in GMP activities.
Unlike Corporate Integrity Agreement which have a defined duration, firms must petition to have the consent decree agreement condition rescinded. Ranbaxy Laboratories has the distinction of having their own page on the FDA website where FDA identifies the enforcement actions that have been taken against the firm including forms , import alerts, warning letters and the specifics of legal actions including a consent decree agreement.
It does not include a tally of product recalled by the firm as a result of these actions. The page provides links to three forms issued to the company beginning in Enforcement actions of this magnitude are not without financial consequences.
Daiichi Sankyo acquired a controlling interest in the company in , and then after failing to make headway in the remediation efforts, sold their stake in the company to Sun Pharmaceuticals. The FDAzilla store has thirteen of their forms available for purchase. Currently four of the Ranbaxy sites, and one site that belongs to Sun Pharmaceuticals are under import alert and cannot import product into the US.
The consent decree agreement remains in place. Genzyme: In May Genzyme entered into a consent decree agreement. Two warning letters to Genzyme are posted on the FDA website, one from and one from For Genzyme, the deficiencies leading to the consent decree agreement were repeatedly identified in inspections and not corrected. They included one data integrity deficiency regarding failure to maintain a computer system in a validated state.
Most were associated with deficiencies in the aseptic manufacture of drug products and the presence of foreign particulates in parenteral product. Here is an abbreviated timeline of the activities from through issuance of the consent decree agreement in Note that the timeline here is much tighter than the one above for Ranbaxy.
Ranbaxy inks consent decree & prepares for $500m penalty
U.S. Food and Drug Administration
Ranbaxy signs consent decree with FDA, may pay upto $500 million penalty