According to several news reports, last month, the drugmaker Warner Chilcott, disclosed that the feds issued a subpoena for information on a wide array of sales and marketing activities. Now, the FDA has issued a warning letter suggesting quality problems have existed for the past five years with the Ovcon birth control pill.
The letter was prompted by an inspection last June of a Warner Chilcott plant in Puerto Rico. And the FDA notes the drugmaker did not thoroughly investigate the reason that certain lots of Ovcon failed stability testing going back to 2006. This can cause a problem with expiration dates. Meanwhile, Warner Chilcott continued to make Ovcon 50 tablets, even though these may have been subpotent.
In its defense, the drugmaker maintained that updated packaging should mitigate any degradation issues, but the FDA responded that a recent lot failed to comply with specifications and there was no documentation to support the assertion that the packaging change would make a difference. Moreover, the agency wrote there was no comprehensive effort to understand the problems.
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